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Friday, October 31, 2008

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition, (Drugs and the Pharmaceutical Sciences)
By Louis Rey, Joan C. May

  • Publisher: Informa HealthCare
  • Number Of Pages: 640
  • Publication Date: 2004-01-21
  • ISBN-10 / ASIN: 0824748689
  • ISBN-13 / EAN: 9780824748685
  • Binding: Hardcover

Product Description:

Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation.

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Emulsions, Foams, and Suspensions: Fundamentals and Applications

Emulsions, Foams, and Suspensions: Fundamentals and Applications.
By Laurier L. Schramm

  • Publisher: Wiley-VCH
  • Number Of Pages: 463
  • Publication Date: 2005-10-21
  • ISBN-10 / ASIN: 3527307435
  • ISBN-13 / EAN: 9783527307432
  • Binding: Hardcover

Product Description:

Until now colloid science books have either been theoretical, or focused on specific types of dispersion, or on specific applications. This then is the first book to provide an integrated introduction to the nature, formation and occurrence, stability, propagation, and uses of the most common types of colloidal dispersion in the process-related industries.
The primary focus is on the applications of the principles, paying attention to practical processes and problems. This is done both as part of the treatment of the fundamentals, where appropriate, and also in the separate sections devoted to specific kinds of industries. Throughout, the treatment is integrated, with the principles of colloid and interface science common to each dispersion type presented for each major physical property class, followed by separate treatments of features unique to emulsions, foams, or suspensions.
The first half of the book introduces the fundamental principles, introducing readers to suspension formation and stability, characterization, and flow properties, emphasizing practical aspects throughout. The following chapters discuss a wide range of industrial applications and examples, serving to emphasize the different methodologies that have been successfully applied.
Overall, the book shows how to approach making emulsions, foams, and suspensions with different useful properties, how to propagate them, and how to prevent their formation or destabilize them if necessary.
The author assumes no prior knowledge of colloid chemistry and, with its glossary of key terms, complete cross-referencing and indexing, this is a must-have for graduate and professional scientists and engineers who may encounter or use emulsions, foams, or suspensions, or combinations thereof, whether in process design, industrial production, or in related R&D fields.

DOWNLOAD LINK:

http://rapidshare.com/files/21459408/Emulsions__Foams__and_Suspensions_-_Fundamentals_and_Applications.rar

Contemporary Drug Synthesis

Contemporary Drug Synthesis.
By Jie Jack Li, Douglas S. Johnson, Drago R. Sliskovic, Bruce D. Roth

  • Publisher: Wiley-Interscience
  • Number Of Pages: 240
  • Publication Date: 2004-06-25
  • ISBN-10 / ASIN: 0471214809
  • ISBN-13 / EAN: 9780471214809
  • Binding: Hardcover

Product Description:

An integrated and insightful look at successful drug synthesis in today's drug discovery market

The pharmaceutical industry is unquestionably vibrant today, with drug synthesis making a vital contribution. Whether in the early developmental stages of identifying and optimizing a lead, or the latter stages of process development and cost-effective scale-up, the ability to design elegant and economical synthetic routes is often a major factor in the eventual viability and commercial success of a drug.

Contemporary Drug Synthesis examines how leading researchers and manufacturers have integrated chemistry, biology, pharmacokinetics, and a host of other disciplines in the creation and development of leading drugs.

Authored by four of the pharmaceutical industry's most respected scientists, this timely volume:

  • Focuses on the processes that resulted in high-profile drugs including Lipitor, Celebrex, Viagra, Gleevec, Nexium, Claritin, and over a dozen others
  • Provides an in-depth introduction to each drug, followed by a detailed account of its synthesis
  • Organizes the drugs into fourteen therapeutic areas for clarity and ease of use
Process chemists provide an essential bridge between chemistry and the marketplace, creating scientifically practical drug processes while never losing sight of the commercial viability of those processes. Contemporary Drug Synthesis meets the needs of a growing community of researchers in pharmaceutical research and development, and is both a useful guide for practicing pharmaceutical scientists and an excellent text for medicinal and organic chemistry students.

DOWNLOAD LINK:
http://rapidshare.com/files/106577603/Contemporary_Drug_Synthesis.pdf

Handbook of Pharmaceutical Analysis

Handbook of Pharmaceutical Analysis (Drugs and the Pharmaceutical Sciences)

Handbook of Pharmaceutical Analysis.

edited by Lena Ohannesian and Anthony J. Streeter

Language: English
ISBN: 0824704622
Format: pdf
Size: 5,6 Mb
Pages: 585 pages

With nearly 2,000 references and more than 300 tables, equations, drawings, and photographs, the Handbook of Pharmaceutical Analysis is an invaluable source for analytical, bioanalytical, pharmaceutical, organic, clinical, medicinal, physical, quality control, and process chemists and biochemists; pharmaceutical scientists; and upper-level undergraduate and graduate students in these disciplines.
Contents
Form Selection of Pharmaceutical Compounds
Preparation of Drug Samples for Analysis
High-Performance Liquid Chromatography
Mass Spectrometry in Pharmaceutical Analysis
Ultraviolet�Visible Spectroscopy
Immunoassay Techniques
Applications of Capillary Electrophoresis Technology in the Pharmaceutical Industry
Atomic Spectroscopy
Luminescence Spectroscopy
Solid-State Nuclear Magnetic Resonance Spectroscopy
Vibrational Spectroscopy
Statistical Considerations in Pharmaceutical Process Development and

DOWNLOAD LINK:

http://rapidshare.com/files/41849348/hopa.rar



Basic Statistics and Pharmaceutical Statistical Applications (Biostatistics (New York, N.Y.), 2.)

Basic Statistics and Pharmaceutical Statistical Applications (Biostatistics (New York, N.Y.), 2.)



  • Publisher: CRC
  • Number Of Pages: 624
  • Publication Date: 1999-06-18
  • Sales Rank: 246268
  • ISBN / ASIN: 0824719670
  • EAN: 9780824719678
  • Binding: Hardcover
  • Manufacturer: CRC
  • Studio: CRC
  • Average Rating: 4
  • Total Reviews: 1
Book Description:

This extremely pragmatic and accessible reference provides scientists with a basic knowledge of statistics, focusing on the practical application of statistical methods to research, quality control, and data analysis. Basic Statistics and Pharmaceutical Statistical Applications explores types of variables, random sampling, probability, measures of central tendency, and hypothesis testing, discusses regression analysis, nonparametric tests, and power determination, and examines study designs, confidence intervals, dissolution testing, and bioequivalence. Also described are the interrelation of hypotheses, test statistics, decision rules, computations, statistical decisions and testing factors.

DOWNLOAD LINK:
http://rapidshare.com/files/47881897/BASTAPHASA.rar

pass: tFBASTAPHASA.rar

All djvu page files are combined into one file, added Contents, Index, Copyright, and Cover pages downloaded from Amazon.The added pages are inserted at the end of the djvu file for easier using of Contents and Index.
Links to Contents and Index added on the first page.

Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded

Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded



  • Publisher: Informa Healthcare
  • Number Of Pages: 840
  • Publication Date: 1998-11-05
  • Sales Rank: 573573
  • ISBN / ASIN: 0824793846
  • EAN: 9780824793845
  • Binding: Hardcover
  • Manufacturer: Informa Healthcare
  • Studio: Informa Healthcare
  • Average Rating: 3.5
  • Total Reviews: 2


Book Description:

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program and suggested the solutions.

DOWNLOAD LINK:

http://rapidshare.com/files/42620576/validation_of_pharmaceutical_processes_sterile_product.zip

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification.
By Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang

  • Publisher: Wiley-Interscience
  • Number Of Pages: 320
  • Publication Date: 2004-01-28
  • ISBN-10 / ASIN: 0471259535
  • ISBN-13 / EAN: 9780471259534
  • Binding: Hardcover

Product Description:

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

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The Laboratory Rat / PlasticComb

The Laboratory Rat / PlasticComb.
By Patrick E. Sharp, Marie C. LaRegina

  • Publisher: CRC
  • Number Of Pages: 240
  • Publication Date: 1998-04-13
  • ISBN-10 / ASIN: 084932565X
  • ISBN-13 / EAN: 9780849325656
  • Binding: Plastic Comb

Product Description:

Laboratory animals, including rats, play an important role in biomedical research and advances. The humane care and management of these animals is an ongoing concern. This guide was created especially for individuals performing research with laboratory rats whose duties include animal facility management, animal husbandry, regulatory compliance, and technical procedures involved with their research. Basic information and common procedures are presented in detail.

DOWNLOAD LINK:

http://rapidshare.com/files/11155510/The.Laboratory.Rat-084932565X.pdf

Thursday, October 30, 2008

Eye Watch On Pharma Industry-III

  • What is Patent / Tradem ark / Copyright ?
A PATENT for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office (USPTO). Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States or, in special cases, from the date an earlier related application was filed, subject to the paym ent of maintenance fees. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. Possessions. Under certain circum stances, patent term extensions or adjustments may be available.

The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. W hat is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO.

There are three types of patents:

1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or com position of matter, or any new and useful improvement thereof;

2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture;

3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant.

A TRADEMARK is a word, name, sym bol, or device that is used in trade with goods to indicate the source of the goods and to distinguish them from the goods of others.

A service mark is the sam e as a trademark except that it identifies and distinguishes the source of a service rather than a product.

The terms “trademark” and “mark” are com monly used to refer to both trademarks and service marks.

Trademark rights may be used to prevent others from using a confusingly similar mark, but not to prevent others from making the sam e goods or from selling the sam e goods or services under a clearly different mark.

Trademarks which are used in interstate or foreign com merce may be registered with the USPTO.

The registration procedure for trademarks and general information concerning trademarks is described on a separate page entitled “Basic Facts about Trademarks”.

A COPYRIGHT is a form of protection provided to the authors of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished.

The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work,to prepare derivative works, to distribute copies or phone records of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.

The copyright protects the form of expression rather than the subject matter of the writing. For example, a description of a machine could be copyrighted, but this would only prevent others from copying the description; it would not prevent others from writing a description of their own or from making and using the machine.

Copyrights are registered by the Copyright Office of the Library of Congress.
  • What is Schedule M ?
It is Indian Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products as per Drugs and Cosm etics Act 1940.

How many types of options for Patent Certifications ?

There are four types and options are there for patent certifications :
Paragraph I / Paragraph II / Paragraph III / Paragraph IV

Paragraph I
  1. No Patent Filed
  2. 21 CFR 314.94(a)(12)(i)(A)(1)
  3. No patents referencing the listed drug in the Orange Book
  4. Firm is aware of non-listed patent
  5. Allows for immediate effective date of approval
  6. Does not mean the patent cannot be enforced
Paragraph II
  1. Patent Has Expired
  2. 21 CFR 314.94(a)(12)(i)(A)(2)
  3. Patent listed in the Orange Book
  4. Cite patent number and provide expiration date
  5. Allows for immediate effective approval date
Paragraph III
  1. Patent Will Expire
  2. 21 CFR 314.94(a)(12)(i)(A)(3)
  3. Listed patent in force at time of subm ission of ANDA
  4. Cite patent number and provide expiration date
  5. State intentions not to market until after patent expires
  6. Allows for approval immediately after expiration of the listed patent
Paragraph IV
  1. Patent Challenge - Invalidity, Non-Infringement or
  2. Unenforceable 21 CFR 314.94(a)(12)(i)(A)(4)
  3. Intent to market prior to expiration of patent
  4. Notification provisions apply
  5. 45-day clock for suit
  6. Allows for immediate effective date of approval if no suit brought within 45 days
  7. If suit brought within 45 days, no approval for 30 months or until court decision
  8. Possible 180-day exclusivity

Toxicological Risk Assessment of Chemicals: A Practical Guide

Toxicological Risk Assessment of Chemicals: A Practical Guide.
By Elsa Nielsen, Grete Ostergaard, John Christian Larsen

  • Publisher: Informa HealthCare
  • Number Of Pages: 448
  • Publication Date: 2008-02-21
  • ISBN-10 / ASIN: 0849372658
  • ISBN-13 / EAN: 9780849372650
  • Binding: Hardcover

Product Description:

Unlike many existing books on toxicology that cover either toxicity of a particular substance or toxicity of chemicals on particular organ systems, Toxicological Risk Assessment of Chemicals: A Practical Guide lays out the principle activities of conducting a toxicological risk assessment, including international approaches and methods for the risk assessment of chemical substances. It illustrates each step in the process: hazard identification, a dose response assessment, and exposure assessment. The book also summarizes the basic concepts of interaction of chemicals in mixtures and discusses various approaches to testing such mixtures.

DOWNLOAD LINK:

#1 ifile.it

Clean-in-Place for Biopharmaceutical Processes

Clean-in-Place for Biopharmaceutical Processes (Drugs and the Pharmaceutical Sciences)
By Dale A. Seiberling

  • Publisher: Informa HealthCare
  • Number Of Pages: 416
  • Publication Date: 2007-10-15
  • ISBN-10 / ASIN: 0849340691
  • ISBN-13 / EAN: 9780849340697
  • Binding: Hardcover

Product Description:

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.

DOWNLOAD LINK:

http://rapidshare.com/files/158557516/tcleanplace.zip

Stockley's Drug Interactions, 8th Edition

Stockley's Drug Interactions, 8th Edition.
By Karen Baxter
  • Publisher: Pharmaceutical Press
  • Number Of Pages: 1464
  • Publication Date: 2007-11-08
  • ISBN-10 / ASIN: 085369754X
  • ISBN-13 / EAN: 9780853697541
  • Binding: Hardcover

Product Description:

First published over twenty years ago, "Stockley's Drug Interactions" is still the most indispensable and authoritative international source of drug interaction information. Based upon the many thousands of published clinical papers and reports, it provides a series of detailed yet concise monographs designed for quick and easy reference. Each monograph contains a summary, clinical evidence for the interaction under discussion, its probable mechanism, clinical importance and management. Individual interactions are assembled alphabetically into chapters, grouped therapeutically, pharmacologically or individually. Both Recommended International Nonproprietary Names (rINN) and US Adopted Names (USAN) are used throughout the book.

DOWNLOAD LINK:

http://rapidshare.com/files/158380318/085369754X.rar

Handbook of Pharmaceutical Excipients

Handbook of Pharmaceutical Excipients.
By Rowe
  • Publisher: Pharmaceutical Press
  • Number Of Pages: 800
  • Publication Date: 2005
  • ISBN-10 / ASIN: 0853696187
  • ISBN-13 / EAN: 9780853696186
  • Binding: Hardcover
DOWNLOAD LINK:
http://rapidshare.com/files/158385018/0853696187.rar

Tablet And Capsule Machine Instrumentation

Tablet And Capsule Machine Instrumentation.
By Peter Ridgway Watt, N. Anthony Armstrong

  • Publisher: Pharmaceutical Press
  • Number Of Pages: 258
  • Publication Date: 2007-11-29
  • ISBN-10 / ASIN: 0853696578
  • ISBN-13 / EAN: 9780853696575
  • Binding: Hardcover

Product Description:

A guide to all aspects of tablet and capsule machine instrumentation in pharmaceutical research, development and production.In order to produce a satisfactory tablet or capsule it is necessary to combine a sound formulation with a proper control of the tabletting or capsule filling process. These considerations involve the need to make accurate measurements and this text provides a practical guide to the techniques and applications of instrumentation used to make these measurements.This text provides a sound understanding of the principles and techniques involved, and of how data generated by instrumented machines can be applied to problems in pharmaceutical research, development and manufacture.It encompasses major advances in instrumentation methodology as well as in both tablet presses and capsule filling equipment. In particular there are new methods of measurement, the feeding of the output of instrumentation into computers has become routine, and instrumentation techniques have been expanded to tablet press simulators, automatic press control and capsule filling equipment.

DOWNLOAD LINK:

http://rapidshare.com/files/158625670/Tab_cap_inst.zip

Nutraceuticals, 2nd Edition

Nutraceuticals, 2nd Edition
By Brian Lockwood
  • Publisher: Pharmaceutical Press
  • Number Of Pages: 426
  • Publication Date: 2007-04-26
  • ISBN-10 / ASIN: 0853696594
  • ISBN-13 / EAN: 9780853696599
  • Binding: Hardcover

Product Description:

Nutraceuticals are complementary medicines of natural origin. Usually obtained from a food source, they are sold as isolated, purified components in pharmacological doses for specific ailments. The international market for nutraceuticals is rapidly expanding and new research is constantly being conducted. New products are appearing on the market, some with novel therapeutic applications. This new edition of "Nutraceuticals" reflects these changes and has broadened its scope and coverage. This authoritative text assesses the medical and scientific evidence for the use of nutraceuticals for prevention or treating important disease states. It will be of value to practicing pharmacists, other healthcare professionals and complementary medicine practitioners.

DOWNLOAD LINK:

http://rapidshare.com/files/158880734/tnutraceuticals2ed.zip


Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance

Global Pharmaceutical Marketing: A Practical Guide to Codes and Compliance
By Judith Grice

  • Publisher: Pharmaceutical Press
  • Number Of Pages: 218
  • Publication Date: 2007-10-27
  • ISBN-10 / ASIN: 0853697175
  • ISBN-13 / EAN: 9780853697176
  • Binding: Paperback

Product Description:

Worldwide, there are varying Codes of Practice/Conduct for the pharmaceutical industry that ensure the industry self-regulates to promote the appropriate use of medicines by operating in a professional, ethical and transparent manner and ensuring high standards.The aim of this book is to aid the understanding of the many pharmaceutical Codes of Practice/Conduct throughout the world. It contains an overview of the guidelines for the promotion of pharmaceutical products in all geographical areas.Each section includes a "general overview" providing a discussion on that particular Code of Practice and differences/similarities with other countries.

DOWNLOAD LINK:

http://rapidshare.com/files/158622608/tglob_pharma_mkt.zip

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007: aka the Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007: aka the Orange Guide.
By MHRA

  • Publisher: Pharmaceutical Press
  • Number Of Pages: 430
  • Publication Date: 2007-02-28
  • ISBN-10 / ASIN: 0853697191
  • ISBN-13 / EAN: 9780853697190
  • Binding: Paperback


Product Description:

Familiarly known as the "Orange Guide," this title combines the major pharmaceutical Regulations, Directives and guidance, which wholesalers and the pharmaceutical industry use as their main source when manufacturing and distributing medicinal products in the EU.

DOWNLOAD LINK:

http://rapidshare.com/files/158554309/OOB2007.zip

Advances In Multi-photon Processes And Spectroscopy

Advances In Multi-photon Processes And Spectroscopy.
By et al S. H. Lin (Editor)

  • Publisher: World Scientific Publishing Company
  • Number Of Pages: 228
  • Publication Date: 2006-04-19
  • ISBN-10 / ASIN: 9812566465
  • ISBN-13 / EAN: 9789812566461
  • Binding: Hardcover

Product Description:

Among others, chemistry, physics, biology, and material sciences have seen a rapid growth in both experimental and theoretical studies of multi-photon processes and spectroscopy of atoms, ions and molecules. This book is an important addition to an advanced series that contains review papers readable not only by active researchers in these areas, but also by those who are intending to enter the field. Written by experts in the area, the reviews are self-contained to allow readers to grasp the key concepts without much preparation. This volume will be useful to active researchers as well as to scientists in biology, chemistry, material sciences, and physics.

DOWNLOAD LINK:

http://rapidshare.com/files/158953597/9812566465.rar

Tuesday, October 28, 2008

Sunday, October 26, 2008

Activating Agents and Protecting Groups, Handbook of Reagents

Activating Agents and Protecting Groups, Handbook of Reagents
for Organic Synthesis.

by
Anthony J. Pearson, William R. Roush
By
Publisher: Wiley
Number Of Pages: 528
Publication Date: 1999-06-22
ISBN-10 / ASIN: 0471979279
ISBN-13 / EAN: 9780471979272
Product Description
Recognising the need for a cost effective reference work that deals not only with the most popular reagents in synthesis but also reaches the widest possible audience of practising organic chemists, the editors of 'The Encyclopedia of Reagents for Organic Synthesis' (EROS) have developed a list of the most important and useful reagents employed in the field, conveniently presented in four separate volumes.
The reagents included in this volume reflect the fact that protecting groups and activation procedures are often used in combination. There are many instances in the synthesis of natural and unnatural products, pharmaceuticals, oligosaccharides, and oligonucleotides, etc., where similar tactics must be employed to prevent undesired activation or reaction of functionality. Accordingly, the most important reagents used to protect amines, alcohols, carboxyl, carbonyl and other reactive functional groups are included in this volume. The list of activating agents includes well known reagents that activate functional groups for substitution or elimination reactions, as well as less traditional examples, e.g. HMPA used to "activate" enolates and alkyllithium reagents to increase the nucleophilicity.
Each article contains all of the information found in EROS as well as expanded related reagents listings and additional references to enable the reader to quickly access a broad range of information that is beyond the scope of the reagent entries themselves. This text will prove an invaluable resource.

Industrial Organic Chemicals, 2nd Edition

By:
Harold A. Wittcoff, Bryan G. Reuben, Jeffery S. Plotkin
Publisher: Wiley-Interscience
Number Of Pages: 696
Publication Date: 2004-07-09
Book Description:
Broadly describes the essential topics of the organic chemicals industry
In the past two decades, the organic chemicals industry has undergone unprecedented restructuring, complicated feedstock problems, and massive shifts of capacity to developing countries. In the developed world, specialty chemicals have gained increasing significance. Although the fundamentals of organic chemical and polymer production have remained largely constant, one needs to be aware of the economic, structural, and political changes in the industry in order to understand its current state.
This much-expanded Second Edition of Industrial Organic Chemicals presents the various technologies and processes involved in the organic chemicals industry as an organized body of knowledge. It describes the chemistry of the seven basic building block chemicals and their derivatives, how they are manufactured, their economic importance, uses, and associated environmental issues.Also covered are two topics essential to an understanding of modern industrial chemistry-catalysis and polymer synthesis.
Key additions to this Second Edition include discussion of:
Sustainability and "green" chemistry
Dendrimers
Metallocenes
Chemicals in biotechnology
Specialty chemicals for pharmaceuticals, electronics, fire retardation, fuel additives, foods, and other uses
Economic, political, and social concepts for understanding future directions of the industry
Industrial Organic Chemicals, Second Edition presents the chemistry of both large-scale and specialty products while taking into account important political, environmental, and economic considerations. It provides both a narrative account of the evolutionof today's industry from the viewpoint of authors intimately involved with the changes, and an essential reference for chemists, chemical engineers, plastics engineers, petroleum engineers, managers, executives, and policy makers working in and with the organic chemical industry.
http://mihd.net/f4mgay
http://rapidshare.com/files/8674093/Industrial_Organic_Chemicals.rar

Genomics in Drug Discovery and Development

Genomics in Drug Discovery and Development.
By Dimitri Semizarov, Eric Blomme

  • Publisher: Wiley
  • Number Of Pages: 480
  • Publication Date: 2008-11-10
  • ISBN-10 / ASIN: 0470096047
  • ISBN-13 / EAN: 9780470096048
  • Binding: Hardcover

Product Description:

Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.

DOWNLOAD LINK:

http://rapidshare.com/files/157420390/0470096047.rar

Coupled Bioluminescent Assays: Methods, Evaluations, and Applications

Coupled Bioluminescent Assays: Methods, Evaluations, and Applications
By Michael J. Corey


  • Publisher: Wiley
  • Number Of Pages: 312
  • Publication Date: 2008-11-24
  • ISBN-10 / ASIN: 0470108835
  • ISBN-13 / EAN: 9780470108833
  • Binding: Hardcover

Product Description:

This book highlights the applications of coupled bioluminescence assay techniques to real-world problems in drug discovery, environmental and chemical analysis, and biodefense. It separates theoretical aspects from the applied sections in a clear and readable way. Coupled Bioluminescent Assays, explains the uses of CB technologies across drug discovery to analyze toxicity, drug receptors, and enzymes. It covers applications in environmental analysis and biodefense, including cytotoxicity, fertilizer and explosives analysis, and nerve agent and pesticide detection. This is the premier reference on coupled bioluminescent assays for chemists, biochemists, and molecular biologists.

DOWNLOAD LINK:

http://rapidshare.com/files/157460594/0470108835_CoupledBio.rar

Eye Watch On Pharma Industry-II

  • What is COPP ?

COPP is Certificate of a Pharmaceutical Product. It is an export certificates for unapproved products, that are not authorized for sale in country, which may be legally exported to foreign governments. It is recom mended by W HO.

  • How many types of application for revision or renewal of Certificate of Suitability ?
Simple Notification
Multiple Notifications (max 3) Simple minor revision
Multiple minor revisions (max 3)
Simple major revision
Multiple major revisions (1 major, max 3 in total) Consolidated revision (more than 3 changes) Quinquennial renewal
Evaluation of sterilisation data

Notifications :
The determination of validity of a notification is com pleted within 2 weeks after receipt of a request.
Then either an acknowl edgement of a valid notification is sent or a revised certificate is granted if necessary.
An application for multiple simultaneous notifications is possible under conditions: - maximum 3 changes.

Minor changes :
T 0 (within 5 days after receipt of the request): a letter of acknowl edgement of receipt is sent to the applicant.
T 30 days: either the request is approved and a revised certificate is granted. or
A letter of request for additional information is sent (clock-stop).
If clock-stop: the applicant is requested to subm it a reply within 30 days.
Failure to subm it a reply in time will lead to the rejection of the request for revision. Again new T0 and new T 30 day’s process will start.

Major changes :
T 0 (within 5 days after receipt): a letter of acknowl edgement of receipt is sent to the applicant.
T 90 days: either the request is approved and a revised certificate is granted. or
A letter of request for additional information is sent (clock-stop).
If clock-stop: the applicant is requested to subm it a reply within 30 days.
Failure to subm it a reply in time will lead to the rejection of the request for revision.
Again new T0 and new T 30 day’s (except TSE certificates: 90 days) process will start.

Quinquennial renewal :
The holder of the certificate should apply for the renewal of their certificate about 6 months prior to expiry date. T0 (within 5 days after receipt): a letter of acknowl edgement of receipt is sent to the applicant.
T 120 days: either approval and a renewed certificate is sent.
or
A letter of request for additional information is sent (clock-stop).
If clock-stop: the applicant is requested to subm it a reply within 30 days.
Failure to subm it a reply in time will lead to the rejection of the request for revision.
Again new T0 and new T 30 day’s (except TSE certificates: 90 days) process will start.

Monographs revisions :
W hen a revised monograph is published, a letter is sent to the relevant holders of to update their dossier. The holder is requested to subm it the data within 90 days.
T0: At receipt of the data, start of evaluation (no letter from EDQM) T120 days: sending of an acknowl edgement of valid data.
or
A letter of request for additional information (clock-stop).
If clock-stop: the applicant is requested to subm it a reply within 30 days.
Failure to subm it a reply in time will lead to the rejection of the request for revision. Again new T0 and new T 30 day’s process will start.
  • What is the Structure and Content of Drug Subm issions In CTD Format ?
Common Technical Docum ent (CTD) is updated and harmonized format for Drug Master File (DMF) for registration
for pharmaceuticals for human use. It is accepted by most of the regulatory agencies. Modules suggested by ICH as follows :

Module 1: Administrative Information and Prescribing Information
Module 2: Common Technical Docum ent Summaries
Module 3: Quality
Module 4: Nonclinical Study Reports
Module 5: Clinical Study Reports
  • What are the topic to be covered in CTD subm ission for Drug Substance ?

Module 3.2 : Body of data

1. General Information
2 Manufacture
3 Characterisation
4 Control of the Drug Substance
5 Reference Standards or Materials
6 Container Closure System
7 Stability
1.1 Nomenclature
1.2 Structure
1.3 General Properties
2.1 Manufacturer(s)
2.2 Description of Manufacturing Process and Process Controls
2.3 Control of Materials
2.4 Controls of Critical Steps and Intermediates
2.5 Process Validation and/or Evaluation
2.6 Manufacturing Process Development
3.1 Elucidation of Structure and other Characteristics
3.2 Impurities
4.1 Specification
4.2 Analytical Procedures
4.3 Validation of Analytical Procedures
4.4 Batch Analyses
4.5 Justification of Specification
7.1 Stability Summary and Conclusions
7.2 Post-approval Stability Protocol and Stability Commitment
7.3 Stability Data
Module 2.3 : Quality Overall Summary
  • guideline is supporting to address the changes in USA ?
W e can address the changes of APIs as per BACPAC [Bulk Actives Post Approval Changes]. But it was withdrawn by
USFDA on 06.01.2006. No other guideline is available from USFDA as on date.

W e can address the changes of formulation related issues as per SUPAC [Scale Up & Post Approval Changes].

  • Which guideline is supporting to address the changes of APIs in Europe ?

As per Guideline of request for revision or renewal of Certificate of Suitability.

  • How to address the variation in EU on Medicines & Health Products ?
  • What is DCGI and NPPA ?

DCGI : Drugs Controller General of India.

NPPA : National Pharmaceutical Pricing Authority [Drug Price Regulator]

  • What is the general procedure for USFDA Audit ?

As per FDA Form 2438 [Effective from February 2006] . There are two basic types of inspections :
1. Surveillance 2. Compliance

Surveillance inspections are conduct ed on a routine basis to satisfy FDA’s responsibilities to inspect drug- manufacturing facilities.

Compliance inspections are conduct ed in response to violative surveillance inspections and when a need arises to inspect a facility for-cause.

This program follows the approach in the main com pliance program.

There are two alternate approaches to inspecting a facility to satisfy FDA inspection obligations :

1. Full Inspection 2. Abbreviated Inspection

A general scheme of systems for auditing the manufacture of API consists of the following:

1. Quality System 2. Facilities and Equipment System
3. Materials System 4. Production System
5. Packagi ng and Labeling System 6. Laboratory Control System
  • What is NDC numbering system ?
National Drug Code is a unique 10-digit, 3-segment number.

1st segment is the Labeller Code. It is assigned by the FDA.

2nd segment is the Product Code. It is to be assigned by the firm with respect to identifies a specific strength, dosage form, and formulation for a particular firm.

3rd segment is the Package Code. It is also to be assigned by the firm to identifies package sizes and types. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
Because of a conflict with the HIPAA standard of an 11 digit NDC, many programs will pad the product code or package code segments of the NDC with a leading zero instead of the asterisk. Since a zero can be a valid digit in the NDC, this can lead to confusion when trying to reconstitute the NDC back to its FDA standard.

Example: 12345-0678-09 (11 digits) could be 12345-678-09 or 12345-0678-9 depending on the firm's configuration.

By storing the segments as character data and using the * as place holders we eliminate the confusion.

In the example, FDA stores the segments as 12345-*678-09 for 5-3-2configuration or 12345-0678-*9 for 5-4-1
configuration.
  • What is SMF ?
SMF (Site Master File) is a docum ent prepared by the manufacturer containing specific and factual Good Manufacturing Practice information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site.

SMF should be concisely written in English and as far as possible no exceed 25-30 A4 sheets. SMF should have edition number and effective date.

W e can make the SMF as per guidelines of Schedule-M, PIC/S, HAS, MCC, ect.

Saturday, October 25, 2008

Eye Watch On Pharma Industry-I

  • What is Drug Registration ?
Once a product has been given authorization for Marketing or free distribution and Entitlement such as first- track procedures, etc.
  • · What are Regulations / Directives?
Regulations / Directives are a form of law, sometimes referred to as subordinate legislation, which define the application and enforcement of legislation. Regulations / Directives are made under the authority of an Act, called an Enabling Act. Regulations / Directives are enacted by the body to whom the authority to make Regulations /Directives has been delegated in the Enabling Act, such as the Governor in Council or a minister, etc.Regulations are USFDA terminology. Directives are EMEA / EDQM terminology.
  • · What are Guidelines?
Guidelines are departmental documents that are used to interpret legislation and/or regulation. Although they may be derived from legislation and are often used to advise how one might comply with a regulation, guidelines do not have the force of law.
  • · What is Marketing Authorization ?
Official document issued by the competent Drug Registration Authorities for the purpose of marketing of a product after evaluation for Quality, Safety and Efficacy.
  • · What is Evaluation ?
Interpret the data and determine if the product has acceptable Quality, Safety and Efficacy.
  • · What is the reason behind change the name of EDQM as EDQM & Health Care ?
European Directorate for the Quality of Medicines (EDQM) was extended to cover two more new areas, i.e., organic transplantation and blood transfusion. So the EDQM & Health Care was started from 14.12.2006 onwards.
  • · How many types of E-DMFs are in place ?
Type A New Active Substances
Type B Existing Active Substances not included in the EP or Pharmacopoeia of an EU Member State.
Type C Pharmacopoeial Active Substances included in the EP or Pharmacopoeia of an EU Member State.
DMF holders should update their DMFs for every five years (Quinquennial Update).
  • · How many types of USDMFs are in place ?
Type I : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer available)
Type II : Drug Substance, Intermediate, and Material used in their preparation or Drug Product
Type III : Packaging Material
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V : FDA Accepted Reference Information
DMF holders should update their DMFs annually (Annual Update). FDA is in the process of sending Overdue
Notification Letters (ONLs) to DMF holders that have not been updated, i.e., no amendments or annual reports in three years. If a DMF holder does not respond to this letter within 90 days, the DMF is retired and is unavailable for review. U.S. standard paper size (8-1/2 by 11 inches) is preferred for USDMF.
Some DMFs may be listed as inactive which are, in fact, still active. Every effort will be made to correct any errors.
The following types of DMFs may be filed as Type V DMFs without requesting prior clearance from FDA :
Manufacturing Site, Facilities, Operating Procedures, and Personnel for sterile manufacturing plants.Contract Facilities for the manufacture of biotech products.

  • · How many types of Canadian DMFs are in place ?
Type I : Active Pharmaceutical Ingredients
Type II : Packaging Materials
Type III : Colourants, Flavours, and Other additives
Type IV : Drug Products.
DMF holders should update their DMFs bi-annually (Biannual Update).

  • · How many types of applications for a new Certificate of Suitability
The following types of application are there for new COS :
Chemical / Chemical and Sterile / TSE / Double (Chemical and TSE) / Double and Sterile / Herbal.

  • What is the criteria for fixation of unknown impurity limit in API ?
As per ICH Q3A,
If maximum Daily Dose is < 2 g / day - Unknown Impurity is 0.10%
Reporting Threshold is 0.05%
Identification Threshold is 0.10% or 1.0 mg per day intake (whichever is lower)
Qualification Threshold is 0.15% or 1.0 mg per day intake (whichever is lower)
If maximum Daily Dose is > 2 g / day - Unknown Impurity is 0.05%
Reporting Threshold is 0.03%
Identification Threshold is 0.05%
Qualification Threshold is 0.05%

  • · What is DCP and What is MRP ?
DCP and MRP’s are EU registration procedures.
Mutual Recognition Procedure is European review procedure for products with an existing Marketing Authorizations.
Only possible, if authorization has already been granted.
Decentralized Procedure is alternative review procedure. Only possible, if no authorization has already been granted.
Procedure will be done among
RMS à Reference Member State
CMS à Concerned Member State
MAH à Marketing Authorization Holder
What is USFDA Form 2656 ?
It is Registration of Drug Establishment / Labeler Code Assignment. It is related to NDC Numbering.
  • · What is USFDA Form 2657 ?
It is Drug Product Listing Form. It is For NDC Number.
  • · What is USFDA Form 482 ?
It is USFDA inspection intimation form. [21 working days is general intimation period]
  • · What is USFDA Form 483 ?
Form 483 is form to furnish USFDA inspectional observations.

Process Engineering Problem Solving: Avoiding "The Problem Went Away, but it Came Back" Syndrome

Process Engineering Problem Solving: Avoiding "The Problem Went Away, but it Came Back" Syndrome
By J. M. Bonem
  • Publisher: Wiley-Interscience
  • Number Of Pages: 284
  • Publication Date: 2008-07-21
  • ISBN-10 / ASIN: 0470169281
  • ISBN-13 / EAN: 9780470169285
  • Binding: Hardcover

Product Description:

Avoid wasting time and money on recurring plant process problems by applying the practical, five-step solution in Process Engineering Problem Solving: Avoiding "The Problem Went Away, but it Came Back" Syndrome. Combine cause and effect problem solving with the formulation of theoretically correct working hypotheses and find a structural and pragmatic way to solve real-world issues that tend to be chronic or that require an engineering analysis. Utilize the fundamentals of chemical engineering to develop technically correct working hypotheses that are key to successful problem solving.

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Alloys: Preparation, Properties, Applications

Alloys: Preparation, Properties, Applications
By Fathi Habashi

  • Publisher: Vch Verlagsgesellschaft Mbh
  • Number Of Pages: 314
  • Publication Date: 1998-11-20
  • ISBN-10 / ASIN: 3527295917
  • ISBN-13 / EAN: 9783527295913
  • Binding: Hardcover

Product Description:

In industry very few metals are used in their pure form; the majority are employed as a combination of a metal with other metals, nonmetals or metalloids. In this way some specific properties are improved, making the alloy more attractive than the pure metal. The present work comprises essential information on alloys in one compact volume.

Classification, properties, preparation, applications, and economic aspects are discussed for alloy steels, primary-metal alloys, light-metal alloys, and some other alloy systems.

The work is based on more than 30 articles from Ullmann's Encyclopedia of Industrial Chemistry and represents the effort of over 60 specialists. It supplies hundreds of top-quality illustrations, diagrams, and charts and provides hand-picked references for further study. An introductory overview of the subject is provided by the editor.

The book is a handy yet authoritative reference work for the practicing metallurgist, but also for physical metallurgists, engineers and scientists industry.

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Oxidizing and Reducing Agents, Handbook of Reagents for Organic Synthesis

Oxidizing and Reducing Agents, Handbook of Reagents for Organic Synthesis
By Steven D. Burke, Rick L. Danheiser

  • Publisher: Wiley
  • Number Of Pages: 564
  • Publication Date: 1999-06-22
  • ISBN-10 / ASIN: 0471979260
  • ISBN-13 / EAN: 9780471979265
  • Binding: Hardcover

Product Description:

Recognising the critical need for bringing a handy reference work that deals with the most popular reagents in synthesis to the laboratory of practising organic chemists, the Editors of the acclaimed Encyclopedia of Reagents for Organic Synthesis (EROS) have selected the most important and useful reagents employed in contemporary organic synthesis.

Handbook of Reagents for Organic Synthesis: Oxidizing and Reducing Agents, provides the synthetic chemist with a convenient compendium of information concentrating on the most important and frequently employed reagents for the oxidation and reduction of organic compounds, extracted and updated from EROS. The inclusion of a bibliography of reviews and monographs, a compilation of Organic Syntheses procedures with tested experimental details and references to oxidizing and reducing agents will ensure that this handbook is both comprehensive and convenient.

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Poisoning and Toxicology Handbook, Fourth Edition

Poisoning and Toxicology Handbook, Fourth Edition (Poisoning and Toxicology Handbook (Leiken & Paloucek's))
By Jerrold B. Leikin, Frank P. Paloucek

  • Publisher: Informa HealthCare
  • Number Of Pages: 1384
  • Publication Date: 2007-08-10
  • ISBN-10 / ASIN: 1420044796
  • ISBN-13 / EAN: 9781420044799
  • Binding: Hardcover

Product Description:

A unique reference containing detailed reviews of more than 900 drugs and poisons, the Poisoning and Toxicology Handbook, Fourth Edition provides the latest information on medicinal, biological, herbal, and non-medicinal agents, and antidotes. Increasing its depth and scope with analyses of newer drugs, chemicals, and environmental toxins, including drugs that have been recently approved by the FDA, the book is a compendium of useful resources. Organized into seven sections, the book provides locations and phone numbers of poison control centers throughout the country, organizations offering information on toxicology, and teratology information services. It presents diagnostic testing and analytical procedures, evaluates the effectiveness of antidotes, and features an extensive symptoms index. The section on special topics provides detailed treatment protocols, hospital preparedness guidelines, and position statements and practice guidelines focused on the treatment of toxicities. This fourth edition keeps you up to date in one of the most exciting and expanding fields in medical science.

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The Toxicologist's Pocket Handbook, Second Edition

The Toxicologist's Pocket Handbook, Second Edition
By Michael J. Derelanko

  • Publisher: Informa HealthCare
  • Number Of Pages: 392
  • Publication Date: 2008-03-24
  • ISBN-10 / ASIN: 1420051385
  • ISBN-13 / EAN: 9781420051384
  • Binding: Paperback

Product Description:

Originally published to provide quick and portable access to the most frequently needed information in the original bestselling CRC Handbook of Toxicology, this new pocketbook is designed to serve the same purpose for the recently revised and expanded Handbook. It continues to provide the most frequently used toxicological reference material in a convenient pocket-sized format. Several sections have been expanded to offer important new information and meet current and emerging areas of concern. A great number of new tables have been added and a few less useful ones eliminated. It also includes a much more timely and reformatted glossary.

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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
By Douglas J. Pisano, David S. Mantus

  • Publisher: Informa HealthCare
  • Number Of Pages: 464
  • Publication Date: 2008-08-11
  • ISBN-10 / ASIN: 1420073540
  • ISBN-13 / EAN: 9781420073546
  • Binding: Hardcover

Product Description:

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

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Tuesday, October 21, 2008

Human Papillomavirus: Iarc Monographs on the Evaluation of Carcinogenic Risks to Human

Human Papillomavirus: Iarc Monographs on the Evaluation of Carcinogenic Risks to Human (Iarc Monographs) (Iarc Monographs)
By International Agency for Research on Cancer

  • Publisher: World Health Organization
  • Number Of Pages: 678
  • Publication Date: 2007-12-30
  • ISBN-10 / ASIN: 9283212908
  • ISBN-13 / EAN: 9789283212904
  • Binding: Paperback

Product Description:

This ninetieth volume of the IARC Monographs on the Evaluation of Carcinogenic Risks to Humans considers human papillomaviruses (HPVs), which were evaluated by a previous Working Group (IARC, 1995). The monograph in the present volume incorporates new data that have become available during the past decade. HPVs represent the most common infectious agents that are transmitted sexually throughout the world; the major risk factors are behaviours associated with sexual activity. Although most infections are asymptomatic and are cleared within a period of 2 years, genital HPV infection can lead to clinical disease, including anogenital warts, cervical neoplasia, cervical cancer and other anogenital cancers. The risk for persistence of infection and progression of the more than 40 genital HPV types to grade 3 cervical intraepithelial neoplasia (CIN3) and cancer differs widely. Persistent infection with carcinogenic HPVs occurs in virtually all cases of cervical cancer.

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Organic Synthesis: State of the Art 2005-2007

Organic Synthesis: State of the Art 2005-2007 (Organic Synthesis: State of the Art)
By Douglass F. Taber

  • Publisher: Wiley-Interscience
  • Number Of Pages: 228
  • Publication Date: 2008-08-11
  • ISBN-10 / ASIN: 0470288493
  • ISBN-13 / EAN: 9780470288498
  • Binding: Hardcover


Product Description:

The second volume in a series, Organic Synthesis: State of the Art 2005-2007 will provide you with a convenient, compact summary of the state of the art of organic synthesis. This reference guide will quickly lead you to the most important recent developments like how scientists can now prepare ketones by directly combining aldehydes with terminal alkenes. Inside, you will find detailed analysis of more than twenty total syntheses, including the Davies Synthesis of (-)-Colombiasin A and (-)-Elisapterosin B, the Overman Synthesis of (-)-Sarain A, and the Sorensen Synthesis of (-)-Guanacastepene E.

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Emerging Contaminants from Industrial and Municipal Waste: Occurrence, Analysis and Effects

Emerging Contaminants from Industrial and Municipal Waste: Occurrence, Analysis and Effects (The Handbook of Environmental Chemistry)
By Damia Barceló, Mira Petrovic

  • Publisher: Springer
  • Number Of Pages: 192
  • Publication Date: 2008-12-01
  • ISBN-10 / ASIN: 3540747931
  • ISBN-13 / EAN: 9783540747932
  • Binding: Hardcover

Product Description:

The group of non-regulated contaminants termed “emerging contaminants” mainly comprises products used in large quantities in everyday life, such as human and veterinary pharmaceuticals, personal care products, surfactants and surfactant residues, plasticizers and various industrial additives. The occurrence of “emerging contaminants” in wastewaters, and their behavior during wastewater treatment and production of drinking water are key issues in the re-use of water resources. Emerging Contaminants from Industrial and Municipal Waste focuses on innovative treatment technologies for the elimination of emerging contaminants from wastewater and drinking water. The respective treatment processes, such as membrane bioreactors, photocatalysis, ozonation and advanced oxidation are dealt with in detail. The book also discusses sources and occurrence of emerging contaminants in municipal and industrial waste, giving a concise and critical overview of state-of-the-art analytical methods for their identification. Further important aspects covered by the book include the acute and chronic effects and overall impact of emerging contaminants on the environment.

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Sunday, October 19, 2008

Preliminary chemical engineering plant design

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Preliminary chemical engineering plant design
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European Standards For Drinking Water

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Chemical Reactor Modeling: Multiphase Reactive Flows

Chemical Reactor Modeling: Multiphase Reactive Flows
By Hugo A. Jakobsen

  • Publisher: Springer
  • Number Of Pages: 1244
  • Publication Date: 2008-07-29
  • ISBN-10 / ASIN: 3540251979
  • ISBN-13 / EAN: 9783540251972
  • Binding: Hardcover


Product Description:

Chemical Reactor Modeling closes the gap between Chemical Reaction Engineering and Fluid Mechanics. It presents the fundamentals of the single-fluid and multi-fluid models for the analysis of single- and multiphase reactive flows in chemical reactors with a chemical reactor engineering rather than mathematical bias. The book discusses numerical methods for solving the resulting equations as well as the interplay between physical and numerical modes. It is organized in 12 chapters combining theoretical aspects and practical applications and covers some of the recent research in several areas of chemical reactor engineering. This book contains a survey of the modern literature in the field of chemical reactor modeling.

The book is written by a Chemical Engineer for Chemical Process Engineers using the standard terminology of this community. It is intended for researchers and engineers who want to develop their own codes, or who are interested in a deeper insight into commercial CFD codes in order to derive consistent extensions and to overcome “black box” practice. It can also serve as a textbook and reference book for both students and practitioners.

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Toxicogenomics: A Powerful Tool for Toxicity Assessment

Toxicogenomics: A Powerful Tool for Toxicity Assessment
By Saura Sahu

  • Publisher: Wiley
  • Number Of Pages: 43216
  • Publication Date: 2008-12-10
  • ISBN-10 / ASIN: 0470518235
  • ISBN-13 / EAN: 9780470518236
  • Binding: Hardcover

Product Description:

Toxicogenomics: A Powerful Tool For Toxicity Testing provides up-to-date state-of-the-art information presented by the recognized experts, and is therefore an authoritative source of current knowledge in this field of research. The potential link between toxicology, genetics and human diseases makes this book very useful to investigators in many and varied disciplines of science and toxicology.

Topics covered include:

  • mechanistic toxicogenomics
  • analysis and interpretation of toxicogenomic data
  • principles of data mining in toxicogenomics
  • design issues in toxicogenomics studies
  • sources of variability in toxicogenomic assays
  • Escherichia coli stress response as a tool for detection of toxicity
  • toxicogenomics as a tool to assess immunotoxicity
  • toxicogenomics and ecogenomics for studying endocrine disruption and basic biology
  • use of toxicogenomics as an early predictive tool for hepatotoxicity
  • nutrigenomics: the application of genomic signatures in nutrition-related research
  • application of toxicogenomics in drug discovery
  • potential uses of toxicogenomic biomarkers in occupational health and risk assessment
  • usefulness of toxicogenomics in the regulatory environment
  • perspectives on toxicogenomics at the US Environmental Protection Agency.
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Engineers Guide to Pharmaceuticals Production

Engineers Guide to Pharmaceuticals Production - IChemE
By Institution of Chemical Engineers (Great Britain)

  • Publisher: Inst of Chemical Engineers UK
  • Number Of Pages: 350
  • Publication Date: 2003-01-01
  • ISBN-10 / ASIN: 0852954409
  • ISBN-13 / EAN: 9780852954409
  • Binding: Hardcover

Product Description:

Most of the significant developments of medicines have occurred in the last 70 years and by a process of trial and error many plants and other substances have been used by man to produce certain pharmalogical effects. This book is a general introduction aimed at all those involved in the engineering stages required for the manufacture of the active ingredient (drugs & primary manufacture) and its dosage forms (secondary manufacture). Chapters also focus on the design of quality control laboratories, process development facilities and pilot plants as these all play a role in ensuring medicines are of an appropriate quality and have their own special problems for pharmaceutical products.

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Tuesday, October 14, 2008

Toxic Chemicals in the Workplace: A Manager's Guide to Recognition, Evaluation, and Control

Toxic Chemicals in the Workplace: A Manager's Guide to Recognition, Evaluation, and Control.
By M.D., T. M. Fraser

  • Publisher: Gulf Professional Publishing
  • Number Of Pages: 192
  • Publication Date: 1996-02-02
  • ISBN-10 / ASIN: 0884158713
  • ISBN-13 / EAN: 9780884158714
  • Binding: Paperback

Product Description:

This book examines toxic chemicals that may be present in the workplace and--with easy-to-understand, nontechnical language--examines the steps an organization can take to manage them.

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Chemical Reaction Hazards, Second Edition

Chemical Reaction Hazards, Second Edition.
By John Barton, Richard Rogers

  • Publisher: Gulf Professional Publishing
  • Number Of Pages: 632
  • Publication Date: 1997-02-27
  • ISBN-10 / ASIN: 088415274X
  • ISBN-13 / EAN: 9780884152743
  • Binding: Hardcover


Product Description:
This revised edition of a best-selling book continues to provide a basis for the identification and evaluation of chemical reaction hazards for chemists, engineers, plant personnel, and students.

Before undertaking the design of a chemical manufacturing process it is vital that the chemical reactions involved be fully understood, potential hazards assessed, and safety measures planned. Chemical Reaction Hazards aims to help the people responsible for this design and operation to meet the general duties of safety.

Two major additions to this revised book are the appendices. One of these describes 100 incidents, illustrating their cause and indicating consequences if appropriate procedures within this guide are not followed. The second provides a practical example of a typical chemical reaction hazard assessment, from consideration of the process description, through experimental testing to the specification of safety measure.

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Advanced Problems in Organic Reaction Mechanisms (Tetrahedron Organic Chemistry)

Advanced Problems in Organic Reaction Mechanisms (Tetrahedron Organic Chemistry)
By McKillop

  • Publisher: Elsevier Science
  • Number Of Pages: 174
  • Publication Date: 1997-12-01
  • ISBN-10 / ASIN: 0080432565
  • ISBN-13 / EAN: 9780080432564
  • Binding: Hardcover

Product Description:

Consisting of 300 problems which challenge the user in terms of providing reasonable mechanistic interpretations of sets of experimental observations. The problems cover all major areas of modern organic chemistry. The idea is that the user tackles a problem by first, if necessary, revising the basic principles of key types of reactions referred to in the setting of the problem, and then attempts to devise a solution. literature references are available.

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Chromatography and Separation Science (SST) (Separation Science and Technology)

Chromatography and Separation Science (SST) (Separation Science and Technology)
By Satinder Ahuja

  • Publisher: Academic Press
  • Number Of Pages: 250
  • Publication Date: 2002-12-30
  • ISBN-10 / ASIN: 0120449811
  • ISBN-13 / EAN: 9780120449811
  • Binding: Hardcover

Product Description:

The basic objectives of this book are to: provide basic information on chromatography and separation science; show how simple extraction and partition processes provide the basis for development of chromatography and separation science; describe the role of chromatography and separation science in various fields; discuss the role of chromatography and separation science in development of new methodology; and present new evolving methods and how to select an optimum method.

· The book covers the fundamental physical and chemical phenomena involved in separations
· Provides a concise overview of the basics of transport phenomena and thermodynamics
· Shows the importance of chromatography within separation science.

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Organosulfur Chemistry

Organosulfur Chemistry: SYNTHETIC ASPECTS (ORGANOSULFUR CHEMISTRY)
By P. PAGE

  • Publisher: Academic Press
  • Number Of Pages: 277
  • Publication Date: 1995
  • ISBN-10 / ASIN: 0125435606
  • ISBN-13 / EAN: 9780125435604
  • Binding: Hardcover.
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Annual Reports in Organic Synthesis

Annual Reports in Organic Synthesis, Volume 2004 (Annual Reports in Organic Synthesis)
By Philip M. Weintraub, Kenneth Turnbull, Jeffrey Sabol, Peter Norris

  • Publisher: Academic Press
  • Number Of Pages: 440
  • Publication Date: 2004-12-17
  • ISBN-10 / ASIN: 0120408341
  • ISBN-13 / EAN: 9780120408344
  • Binding: Paperback
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http://www.filefactory.com/file/a66cb8/n/0120408341_zip