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Saturday, February 20, 2010
Handbook of Phase Change: Boiling and Condensation
Convective Boiling and Condensation
Saturday, February 13, 2010
The Textbook of Pharmaceutical Medicine
- Publisher: BMJ Books / Wiley-Blackwell
- Number Of Pages: 776
- Publication Date: 2009-12-14
- ISBN-10 / ASIN: 1405180358
- ISBN-13 / EAN: 9781405180351
The Textbook of Pharmaceutical Medicine is a standard reference for all those working in pharmaceutical medicine and the recognised text for the UK Faculty of Pharmaceutical Medicine Diploma. This is a comprehensive volume covering the processes by which medicines are developed, tested and approved. Regulations for drug development in the UK, EU, USA, Australia and Japan are discussed, providing relevant information for drug approval in the main continents where new drugs are developed.
The chapters are written by leading academics, medical directors and lawyers, providing authoritative and in-depth information for trainees on the Faculty course, and for physicians working in the pharmaceutical industry. As well as thorough updating of the regulatory chapters, the 6th edition includes chapters on these vital new areas:
- Paediatric regulation
- Ethics
- Due diligence and the pharmaceutical physician.
Introduction to Modern Liquid Chromatography, Third Edition
- Publisher: Wiley
- Number Of Pages: 912
- Publication Date: 2009-12-09
- ISBN-10 / ASIN: 0470167548
- ISBN-13 / EAN: 9780470167540
The latest edition of the authoritative reference to HPLC
High-performance liquid chromatography (HPLC) is today the leading technique for chemical analysis and related applications, with an ability to separate, analyze, and/or purify virtually any sample. Snyder and Kirkland's Introduction to Modern Liquid Chromatography has long represented the premier reference to HPLC. This Third Edition, with John Dolan as added coauthor, addresses important improvements in columns and equipment, as well as major advances in our understanding of HPLC separation, our ability to solve problems that were troublesome in the past, and the application of HPLC for new kinds of samples.
This carefully considered Third Edition maintains the strengths of the previous edition while significantly modifying its organization in light of recent research and experience. The text begins by introducing the reader to HPLC, its use in relation to other modern separation techniques, and its history, then leads into such specific topics as:
- The basis of HPLC separation and the general effects of different experimental conditions
- Equipment and detection
- The column—the "heart" of the HPLC system
- Reversed-phase separation, normal-phase chromatography, gradient elution, two-dimensional separation, and other techniques
- Computer simulation, qualitative and quantitative analysis, and method validation and quality control
- The separation of large molecules, including both biological and synthetic polymers
- Chiral separations, preparative separations, and sample preparation
- Systematic development of HPLC separations—new to this edition
- Troubleshooting tricks, techniques, and case studies for both equipment and chromatograms
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 1: Compressed Solid Products
- Publisher: Informa Healthcare
- Number Of Pages: 648
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081160
- ISBN-13 / EAN: 9781420081169
The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on.
Highlights from Compressed Solid Products, Volume One include:
- formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition
- the essentials of what you need to be aware of when establishing a manufacturing process based on the formulations presented
- identification and inclusion of the most popular prescription products, a critical list for the selection of products.
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 2: Uncompressed Solid Products
- Publisher: Informa Healthcare
- Number Of Pages: 392
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081187
- ISBN-13 / EAN: 9781420081183
Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products.
Highlights from Uncompressed Solid Products, Volume Two include:
- the fundamental issues of good manufacturing practices
- formulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticles
- access to US FDA guidelines, as well as all major guidelines around the world
- identification and inclusion of the most often approved capsules and powders in the US.
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 3: Liquid Products
- Publisher: Informa Healthcare
- Number Of Pages: 400
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081233
- ISBN-13 / EAN: 9781420081237
While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.
Highlights from Liquid Products, Volume Three include:
- practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing
- access to what an FDA auditor would be looking for during a liquid manufacturing audit
- issues that may arise during a US FDA inspection
- the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines.
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 4: Semisolid Products
- Publisher: Informa Healthcare
- Number Of Pages: 376
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081268
- ISBN-13 / EAN: 9781420081268
The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations.
Highlights from Semisolid Products, Volume Four include:
- coverage of over 350 formulations
- valuable information on the difficult area of compliance
- changes to approved new drug applications and abbreviated new drug applications
- the evolving guidelines of ICH and when to conduct a regulatory review.
Handbook of Pharmaceutical Manufacturing Formulations Series, Second Edition, Volume 5: Over-the-Counter Products
- Publisher: Informa Healthcare
- Number Of Pages: 480
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081284
- ISBN-13 / EAN: 9781420081282
Over-the-Counter products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separately because of their development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products.
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Highlights from Over-the-Counter Products, Volume Five include:
- solids, liquids, and suspensions
- practical advice on how to bring manufacturing practices into compliance with regulatory requirements
- cGMP considerations in great detail
- a large number of formulations of coatings of solid dosage forms.
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 6: Sterile Products
By Sarfaraz K. Niazi
- Publisher: Informa Healthcare
- Number Of Pages: 464
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081306
- ISBN-13 / EAN: 9781420081305
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.
Highlights from Sterile Products, Volume Six include:
- formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
- specifications of a manufacturing facility to manufacture compliant sterile products
- NDA or aNDA filing requirements of sterile products
- an alphabetical presentation of formulations of pharmaceutical products based on their generic names
Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Assessments of Extractables and Leachables for Pharmaceutical Products
- Publisher: Wiley-Interscience
- Number Of Pages: 379
- Publication Date: 2009-06-02
- ISBN-10 / ASIN: 0470281766
- ISBN-13 / EAN: 9780470281765
Dennis Jenke
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Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)
- Publisher: Informa Healthcare
- Number Of Pages: 2094
- Publication Date: 2009-09-21
- ISBN-10 / ASIN: 1420081063
- ISBN-13 / EAN: 9781420081060
An authoritative and practical guide to the art and science of formulating drugs.
With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.
A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.
Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:
- cGMP compliance
- pre-approval inspections
- stability and bioequivalence testing
- packaging commodity development
- common difficulties in formulating drugs
- changes to aNDAs
Preclinical Drug Development, Second Edition (Drugs and the Pharmaceutical Sciences)
- Publisher: Informa Healthcare
- Number Of Pages: 536
- Publication Date: 2009-09-25
- ISBN-10 / ASIN: 1420084720
- ISBN-13 / EAN: 9781420084726
Preclinical Drug Development, Second Edition discusses the broad realm of preclinical drug development, ranging from assessment of pharmacology and toxicology to the industry trends and regulatory expectations and requirements that support clinical trials. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.
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