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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.

Publication Info.	Amsterdam : Elsevier, [2014]
	Š2014

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Location	Call No.	OPAC Message	Status
Axe Elsevier ScienceDirect Ebook	Electronic Book	---	Available

Description	1 online resource (389 pages) : illustrations
	text txt rdacontent
	computer c rdamedia
	online resource cr rdacarrier
Series	Progress in Pharmaceutical and Biomedical Analysis
	Progress in pharmaceutical and biomedical analysis.
Bibliography	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.
Subject	Drugs -- Analysis -- Methodology.
	Pharmaceutical Preparations -- methods
	Pharmaceutical Preparations -- standards
	Médicaments -- Analyse -- Méthodologie.
	MEDICAL -- Pharmacology.
	Drugs -- Analysis -- Methodology
Added Author	Riley, Christopher M.
	Rosanske, Thomas W.
	Riley, Shelley R. Rabel.
Other Form:	Print version: Specification of drug substances and products. Amsterdam : Elsevier, 2014 9780080983509 (DLC) 2013444132
ISBN	9780080983431 (electronic bk.)
	008098343X (electronic bk.)
	9780080983509
	0080983502 (hbk.)
Standard No.	AU@ 000059642881
	AU@ 000060553554
	DEBBG BV043216080
	DEBBG BV044063585
	DEBSZ 405351305
	DEBSZ 481276637
	NLGGC 370258916