Online Training module

 

Here below a few of training module is presented on GMP.

 

Training Module

Basic GMP Basic training module       | WHO | Supplementary training module        | WHO | Training and guidance                       | IPCS |

FDA publishes guidance document on capillary Electrophoresis

The ICH Steering Committee recommends that the analytical procedures described in the official pharmacopoeial texts, Ph. Eur. 2.2.47. Capillary Electrophoresis, JP General Information. Capillary Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles – Capillary Electrophoresis,  can be used as interchangeable in the ICH regions. To view the guidance, CE FDA Guidance

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Uncertainty of Measurement-Part 1: General OMCL Policy for implementation of Measurement of Uncertainty in Compliance Testing

Uncertainty of Measurement-Part 2: OMCL Policy on the Estimation and Application of Uncertainty in Analytical Measurement

 

Implementation of ISO/ISE 17025 by Agilent technoligies

 

To get the copy of Analytical instrument qualification from Agilent technologies click the link  - Analytical Instrument Qualification

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Guidance for UK Manufacturer’s Licence and Manufacturer’s Authorisation (for Investigational Medicinal Products) Holders on the use of UK Stand Alone Contract Laboratories

This document:

• Defines a stand alone contract laboratory in relation to quality control testing of medicinal products.

• Provides guidance as to when a contract laboratory must be named on a manufacturer’s licence for relevant medicinal products for human and veterinary use and/or a manufacturer’s authorisation for investigational medicinal products.

• Is applicable to all manufacturing licence holders, i.e. import, export, herbals and specials.

• Provides guidance as to when a contract laboratory is not required to be named on a manufacturer’s licence or authorisation.

• Outlines the MHRA’s criteria for inspection of contract laboratories.

This guidance can be downloaded by clicking Guidance .

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A primer for Good laboratory Practice and Good Manufacturing Practice - For Analytical Laboratories

 

WHO good practice for pharmaceuticals quality control laboratory(draft)

 

Analytical Balance

 

NIST - weight and measurement-calibration procedure

 

NIST - Weight classification

 

Balance calibration procedure

 

A guide for Proper weighing of lab balance by Mettler

 

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HPLC Column comparison

 

To find out alternative column for your column of interest.

 

HPLC Column comparison - USP Database

 

HPLC Troubleshooting guide

 

From waters

 

From sigma-aldrich

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Instrument calibration

 

1. Disolution Apparatus 1 & 2 - Mechanical calibration

 

Procedure - FDA procedure - Dissolution - Mechanical calibration

 

Calibration of Dissolution Apparatus 1&2

Recently FDA has released a new guidance on Calibration of disolution apparatus 1 & 2. This guidance document more emphasis on enhanced mechanical calibration than chemical performance verification test. This guidance also recommends to manufacturer take appropriate control to handle recognised source of significant variablity during dissolution testing like dissolved gases, vibration and vessel dimensions. For more information go through the link .Guidance to industry -Dissolution

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                        Dissolution procedure toolkit

 

USP released the version 2 of dissolution tool kit procedure for mechanical calibration and performance verification test apparatus 1 & 2. The dissolution toolkit provides a description of best practices associated with the mechanical calibration and performance verification test for the USP basket and paddle dissolution apparatuses and test assemblies.This second version of the dissolution toolkit represents a continuing effort to provide detailed information describing the procedures that if used will assure a properly qualified dissolution test assembly. For more information click Disolution Toolkit Procedure Version-2.

 

To refer version-1 click Dissolution Toolkit version-1

 

Further USP established a new acceptance criteria for current lot of Prednisone tablet. For more information click the link Performance of Equipment to Test Dissolution of Medications Further Assured

 

2. Prednisone tablet for PVT - New lot - P1I303

 

Prednisone Tablet for PVT - New lot released on March 2010 

 

Prednisone Tablet for PVT - A new lot is released on March 01, 2010 Lot No.P1I300 valid through Feb 29, 2012 with test procedure an optional two stage test and calculation example. On April 30, 2010, Lot P0E203 will no longer be official.

 

Note: There was an error in the initial USP certificate dated Feb.22, 2010. It is now corrected. For corrected certificate click Prednisone Tablet for PVT - New lot released on March 2010.

 

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Instrument Qualification

 

Qualification of Equipment (Core document)

Annex 1: Qualification of HPLC Equipment

Annex 2: Qualification of GC Equipment

Annex 3: Qualification of UV-Visible Spectrophotometers

Annex 4: Qualification of IR Spectrophotometers

Annex 5: Qualification of Automatic Titrators

 

NEW: Annex 6: Qualification of piston pipettes

 

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Result & Reports

 

Evaluation & Reporting of Results

Liquid Polymorphism

 

The Advances in Chemical Physics series-the cutting edge of research in chemical physics
The Advances in Chemical Physics series provides the chemical physics and physical chemistry fields with a forum for critical, authoritative evaluations of advances in every area of the discipline.

Filled with cutting-edge research reported in a cohesive manner not found elsewhere in the literature, each volume of the Advances in Chemical Physics series presents contributions from internationally renowned chemists and serves as the perfect supplement to any advanced graduate class devoted to the study of chemical physics.

This volume explores:

* Electron Spin Resonance Studies of Supercooled Water
* Water-like Anomalies of Core-Softened Fluids: Dependence on the Trajectories in (P, ?, T) Space
* Water Proton Environment: A New Water Anomaly at Atomic Scale?
* Polymorphism and Anomalous Melting in Isotropic Fluids
* Computer Simulations of Liquid Silica: Water-Like Thermodynamic and Dynamic Anomalies, and the Evidence for Polyamorphism.

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Who's Who in Analytical Chemistry: Europe

 

This comprehensive directory comprises information on more than 800 European analytical scientists and includes complete addresses, telephone and fax numbers, fields of expertise, research topics as well as consulting activities. Private, governmental and official laboratories are also included. Exhaustive indexes allow easy access to all entries. The increasing demand for internationally approved professionals in all fields of analytical chemistry makes this volume an invaluable source of information for the analytical industry, R + D institutions, consultants, private laboratories and university departments seeking for cooperation and service partners or consultancy.

DOWNLOAD LINK:
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InTeOp | 2012 | ISBN: 9535108375 9789535108375 | 154 pages | PDF | 8 MB

The current text deals with several, very important topics of modern, Analytical Chemistry, such as analytical method validation in biotechnology today, principal component analysis, kinetic methods of analysis using potentiometric and spectrophotometric detectors, the current status of Analytical Chemistry and where it may move in the future, peptide and amino acid separations and identification, and several other, related topics in this growing and increasingly important area of Chemistry, in general.

Download

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English | ISBN: 0123744849 | edition 2009 | PDF | 1124 pages | 39.9 Mb

This is the first book that offers in-depth coverage of individual toxicants, target organ toxicity, major incidents, toxic effects in humans, animals and wildlife, biosensors, biomarkers, on-site and laboratory analytical methods, decontamination and detoxification procedures, prophylactic, therapeutic and countermeasures, and the role of homeland security.

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Practical Statistics for the Analytical Scientist: A Bench Guide (Valid Analytical Measurement)

Stephen L.R. Ellison, Vicki J. Barwick, Trevor J. Duguid Farrant

Year: 2009

Edition: 2nd ed.

Language: English

Pages: 268

Download (pdf, 3.24 MB

Difference Between PURITY, ASSAY & POTENCY

 

Purity:

 

It is calculated by area normalisation method, it can be directly find out by chromatograms obtained from HPLC.

 

% Purity = (Area of desired peak / Sum of area of all peaks) x 100

 

Assay:

  

It is calculated against standard. It may be of following types:

 

1) On as is basis = (Area of sample / Area of standard) x (conc. of standard / conc. of sample) x potency or assay of standard

2) On anhydrous basis = (Assay on as is basis / 100 – moisture) x 100

3) On dried basis = (Assay on as is basis / 100 – LOD) x 100

 

Potency:

 

 100 – (moisture or LOD + residual solvents + heavy metals + sulphated ash + impurities)

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Author(s):	Angel Rios, Alberto Escarpa, and Bartolome Simonet
Publisher:	Wiley

Date:	2009	Format:	PDF	Language:	English	ISBN10:	0470061103
Pages:	384	OCR:		Quality:		ISBN13:

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Author(s): Brian S. Middleditch Publisher: Elsevier Science Ltd Date: 1989-01-01 Format: djvu Language: English ISBN10: 0444871586 Pages: 1030 OCR: Quality: ISBN13: 9780444871589

Excel for Chemists: A Comprehensive Guide

Author(s):	E. Joseph Billo
Publisher:

Date:	2011-09-21	Format:	PDF	Language:	English	ISBN10:	047038123X
Pages:	760	OCR:		Quality:		ISBN13:	9780470381236

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Food Analysis (Food Science Text Series)|S. Suzanne Nielsen (Editor)|Edition: 4th ed. 2010|PDF

This book provides information on the techniques needed to analyze foods in laboratory experiments. All topics covered include information on the basic principles, procedures, advantages, limitations, and applications. This book is ideal for undergraduate courses in food analysis and is also an invaluable reference to professionals in the food industry. General information is provided on regulations, standards, labeling, sampling and data handling as background for chapters on specific methods to determine the chemical composition and characteristics of foods. Large, expanded sections on spectroscopy and chromatography also are included. Other methods and instrumentation such as thermal analysis, ion-selective electrodes, enzymes, and immunoassays are covered from the perspective of their use in the analysis of foods. A website with related teaching materials is accessible to instructors who adopt the textbook.

Download free Food Analysis Food Science Text Series

Download Link: 

Depositfiles          

 

Holt Chemistry By R. Thomas Myers, Keith B. Oldham, Salvatore Tocci

Holt Chemistry curriculum emphasizes the fundamentals of chemistry and problem solving, while covering traditional chemistry topics as well as newly emerging topics. It presents a balanced approach to conceptual and problem-solving instruction.

The content of the Holt Chemistry Student Edition is organized around main ideas. Strategic vocabulary is highlighted, critical thinking questions and reading questions are included to test student comprehension. Additionally, key formulas are highlighted to help students focus on the key parts of the formula. The unknown variables in the sample problems are highlighted and color coded throughout the book helping students focus on the problem solving process as they solve the practice problems.
 

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Try these links for chemistry books

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Advanced Organic Chemistry 6th ed., by Michael B. Smith, Jerry March(28.79 MB)
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Mass Spectrometry Basics by Christopher G. Herbert, Robert A. W. Johnstone (32.98 MB)
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Thermodynamics for Chemists, Glasstone (31.49 MB)
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Oxford Dictionary of Chemistry
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Fourier Transforms - New Analytical Approaches and FTIR Strategies

Edited by Goran Nikolic, ISBN 978-953-307-232-6, Hard cover, 520 pages, Publisher: InTech, Published: April 01, 2011 under CC BY-NC-SA 3.0 license
DOI: 10.5772/2040

New analytical strategies and techniques are necessary to meet requirements of modern technologies and new materials. In this sense, this book provides a thorough review of current analytical approaches, industrial practices, and strategies in Fourier transform application.

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PDF file (zipped) 32.1 MB

Pesticides - Strategies for Pesticides Analysis

Edited by Margarita Stoytcheva, ISBN 978-953-307-460-3, Hard cover, 404 pages, Publisher: InTech, Published: January 21, 2011 under CC BY-NC-SA 3.0 license
DOI: 10.5772/565

This book provides recent information on various analytical procedures and techniques, representing strategies for reliability, specificity, selectivity and sensitivity improvements in pesticides analysis. The volume covers three main topics: current trends in sample preparation, selective and sensitive chromatographic detection and determination of pesticide residues in food and environmental samples, and the application of biological (immunoassays-and biosensors-based) methods in pesticides analysis as an alternative to the chromatographic methods for "in situ" and "on line" pesticides quantification. Intended as electronic edition, providing immediate "open access" to its content, the book is easy to follow and will be of interest to professionals involved in pesticides analysis.

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Principles of Instrumental Analysis 6th Edition

Principles of Instrumental Analysis 6th Edition PDF Solutions Manual Free Download ebook

Principles of Instrumental Analysis 6th Edition by Douglas A. Skoog, F. James Holler, Stanley R. Crouch has long been the standard for courses that deal with the principles and applications of modern analytical instruments. Now with their new Sixth Edition, authors Douglas A. Skoog, F. James Holler, and Stanley R. Crouch infuse their popular text with updated techniques as well as new Instrumental Analysis in Action case studies. The book's updated material enhances its proven approach, which places an emphasis on the theoretical basis of each type of instrument, its optimal area of application, its sensitivity, its precision, and its limitations.

Principles of Instrumental Analysis 6th Edition also introduces students to elementary analog and digital electronics, computers, and treatment of analytical data. A book companion website is available, providing students with tutorials on instrumental methods, Excel files of data analysis and simulations of analytical techniques to help them visualize important concepts in this course, and selected papers from the chemical literature to stimulate interest and provide background information for study.

The Principles of Instrumental Analysis 6th Edition book is jewel for chemist knowledge in junior or senior level. The best feature is that it provides a practical approach to understand the instruments foundamental behavior. Which is helpful for analytical chemist profession.

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World Of Chromatography

HPLC and CE: Principles and Practice presents the latest information on the most powerful separation techniques available: high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE). Fundamental theory, instrumentation, modes of operation, and optimization of separations are presented in a concise, non-technical style to help the user in choosing the appropriate technique quickly and accurately. Well- illustrated and containing convenientend-of-chapter summaries of the major concepts, the book provides in-depth coverage of trouble-shooting, improvement of resolution, data manipulation, selectivity, and sensitivity.
Graduate students, technicians, and researchers who must use separations with little or no background in analytical chemistry can overcome separation anxiety and get started in obtaining the best possible separations in minimal time. The book will alsobe useful to analytical chemists who need a better understanding of theory and processes.

Key Features
* Fully up-to-date information on both HPLC and CE includes troubleshooting and comparisons of the two techniques
* Applicable to a wide variety of separation problems
* Covers basic concepts governing any separation as well as instrumentation and how to use it
* Helps the user to obtain optimal resolution in minimal time
* Contains information on special procedures such as chiral separations, affinity chromatography, and sample preparation
* Includes information on upcoming trends such as miniaturization
* Major concepts in each chapter are organized to allow access to information easily and quickly
* Contains practical bibliography for accessing the literature

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The use of High Performance Liquid Chromatography (HPLC) techniques in the study of enzymatic reactions has grown significantly since the publication of the first edition of this highly successful book: the role of enzymes in biological research has expanded; the application of HPLC and enzymes has extended to more disciplines; advances in separation techniques and instrumentation have increased the capability of HPLC; and the discovery of new enzymes has spawned new methods of analysis.

High Performance Liquid Chromatography in Enzymatic Analysis, Second Edition addresses these developments in its coverage of the refinements of HPLC methods and their use in a wide range of laboratory applications. It offers the same practical approach found in the first edition, incorporates a wealth of new information into existing chapters, and adds new chapters to deal with new applications, including capillary electrophoresis, forensic chemistry, microdialysis, and the polymerase chain reaction. Topics include:
* Application of HPLC to the assay of enzymatic activities
* Concepts and principles of HPLC, including the latest technological advances
* Concepts and principles of capillary electrophoresis (CE)
* Strategy for design of an HPLC/CE system for assay of enzyme activity
* Preparation of enzymatic activities from tissues and single cells
* Analysis of enzymatic activities in body fluids, including chromatobiosis
* HPLC for the identification of new enzymatic activities
* Fundamentals of the polymerase chain reaction
* HPLC in forensics
* Survey of enzymatic activities assayed by the HPLC method, including many new categories
* Multienzyme systems, including many new examples
* HPLC in the analysis of contaminated food

"It is the ability of HPLC to accomplish separations completely and rapidly that led to its original application to problems in the life sciences, particularly those related to purification. An analysis of the literature revealed that this technique was used primarily for the purification of small molecules, macromolecules such as peptides and proteins, and more recently, antibodies. This application to purification has all but dominated the use of the method, and there has been a plethora of books, symposia, and conferences on the use of HPLC for these purposes. However, it was only a matter of time before others began to look beyond and to explore the possibilities that result from the capacity to make separations quickly and efficiently." --from the preface to the First Edition

Easy to read and full of practical advice and hundreds of diagrams and examples, High Performance Liquid Chromatography in Enzymatic Analysis, Second Edition is an invaluable resource for students, researchers, and laboratory workers in analytical chemistry and biochemistry, molecular biology and cell biology, and for anyone interested in keeping up with this fast-growing field.

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Gradient elution demystified

Of the various ways in which chromatography is applied today, few have been as misunderstood as the technique of gradient elution, which presents many challenges compared to isocratic separation. When properly explained, however, gradient elution can be less difficult to understand and much easier to use than often assumed.

Written by two well-known authorities in liquid chromatography, High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model takes the mystery out of the practice of gradient elution and helps remove barriers to the practical application of this important separation technique. The book presents a systematic approach to the current understanding of gradient elution, describing theory, methodology, and applications across many of the fields that use liquid chromatography as a primary analytical tool.

This up-to-date, practical, and comprehensive treatment of gradient elution:
* Provides specific, step-by-step recommendations for developing a gradient separation for any sample
* Describes the best approach for troubleshooting problems with gradient methods
* Guides the reader on the equipment used for gradient elution
* Lists which conditions should be varied first during method development, and explains how to interpret scouting gradients
* Explains how to avoid problems in transferring gradient methods

With a focus on the use of linear solvent strength (LSS) theory for predicting gradient LC behavior and separations by reversed-phase HPLC, High-Performance Gradient Elution gives every chromatographer access to this useful tool.

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This Second Edition of the classic handbook details how to set up an HPLC system that capitalizes on the latest innovations. It covers new techniques in high-temperature, micro-flow, and ultra-fast chromatography, the linking of an HPLC to a mass spectrometer, and more. Complete with a CD-ROM and appendices, this guide has everything chromatographers need to know to confidently separate, identify, purify, and quantify compounds.

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Oxidative Stress and Antioxidant Protocols (Methods in Molecular Biology)

onald Armstrong updates and expands his highly praised Free Radical and Antioxidant Protocols (Humana, 1998) with a collection of new and valuable methods for evaluating the pertubations in cell function resulting from increased oxidative stress. Presented in a user-friendly, step-by-step format, these readily reproducible techniques cover both free radical-derived and antioxidant biomarkers. The methodologies demonstrated include ELISA, HPLC, infrared spectroscopy, gas chromatography-mass spectroscopy, immunoblotting, electroelution fractionation, isoelectric focusing, voltametry, and electron paramagnetic resonance imaging. Special emphasis is given to the separation of complex mixtures of plant antioxidants, soft drug design to protect from toxic oxidative metabolites, in vitro oxidation conditions, and correcting for random measurement error to improve statistical interpretation. A soon-to-be-published companion volume, Oxidants and Antioxidants: Ultrastructural and Molecular Biology Protocols (0-89603-851-3), contains state-of-the-art molecular and ultrastructural methods that expand the total number of protocols to 109 assays.

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A unique approach to solving HPLC problems.
Everyone who bought "Problem Solving in HPLC" by Stavros Kromidas will equally benefit from nearly 100 new practical examples for optimization, trouble-shooting, and instrument performance given in this sequel.
The author provides
- guidance for selecting and evaluating methods, intstruments and columns,
- practical help with everyday trouble-shooting,
- advice for optimizing separations, always explaining the reason why.
In each case the problem, the solution and the conclusions are presented over a maximum of 4 pages, and in addition the book contains manufacturers' addresses, references, data tables and checklists.

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High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective.HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.

* Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
* Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
* Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase
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http://rapidshare.com/files/74149161/HPLC_Method_Develop_Pharma.zip

Hands-on experts from academia and industry comprehensively describe how to successfully perform all the critical HPLC techniques needed for the analysis of peptides and proteins. The methods range from commonly used techniques to those for capillary to large-scale preparative isolation. The authors have also presented a number of specific applications as case studies to illustrate the analytical approaches to a particular separation or assay challenge, with examples drawn from contemporary fields in biochemistry and biotechnology.

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http://rapidshare.com/files/78258935/HPLC_Peptides_Proteins.zip

Development and Validation of HPLC Methods For Analytical And Preparative Purposes

Liquid chromatography (LC) is a separation method of great importance to the chemical, pharmaceutical and biotechnological industry. The principle is that a sample of a solution of the substances is injected into a column of an porous material (stationary phase) and a liquid (mobile phase) is pumped through the column. The separation of substances is based on differences in rates of migration through the column arising from different partition of the substances between the stationary and the mobile phase. Depending on the partition behavior of the different types of substances, these will elute at different times from the column outlet.

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Statistics in Drugs Research

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Skoog Fundamentals Of Analytical Chemistry

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