Franklin

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:
Amsterdam : Elsevier, [2014]
Format/Description:
Book
1 online resource (389 p.)
Edition:
2nd ed.
Series:
Progress in Pharmaceutical and Biomedical Analysis
Progress in Pharmaceutical and Biomedical Analysis
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Details

Subjects:
Drugs -- Analysis -- Methodology.
Form/Genre:
Electronic books.
Language:
English
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 d
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.
Notes:
Description based upon print version of record.
Includes bibliographical references and index.
Description based on online resource; title from PDF title page (ebrary, viewed October 8, 2013).
Contributor:
Riley, Christopher M.
Rosanske, Thomas W.
Riley, Shelley R. Rabel.
ISBN:
0-08-098343-X
OCLC:
863821936