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Title Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA ; Riley and Rabel Consulting Services, Maryville, MO, USA.
Imprint Amsterdam : Elsevier, [2014]
©2014

Series Progress in Pharmaceutical and Biomedical Analysis
Progress in pharmaceutical and biomedical analysis.
Subject Drugs -- Analysis -- Methodology.
Pharmaceutical Preparations -- methods
Pharmaceutical Preparations -- standards.
Alt Name Riley, Christopher M.
Rosanske, Thomas W.
Riley, Shelley R. Rabel.
Description 1 online resource (389 pages) : illustrations
Bibliography Note Includes bibliographical references and index.
Contents Part 1. Introduction -- part 2. Universal tests -- part 3. Specific tests : drug substance -- part 4. Specific tests : drug product -- part 5. Pharmacopeial methods -- part 6. Microbial methods -- part 7. Biological fluids.
Note Online resource; title from PDF title page (ebrary, viewed October 8, 2013).
Summary Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity.
ISBN 9780080983431 (electronic bk.)
008098343X (electronic bk.)
9780080983509
0080983502 (hbk.)
OCLC # 861537317
Additional Format Print version: Specification of drug substances and products. Amsterdam : Elsevier, 2014 9780080983509 (DLC) 2013444132


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