Specification of Drug Substances and Products : Development and Validation of Analytical Methods
Language: English
Published by Elsevier Inc, 2020
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
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Add to basketItem description from seller
nach der Bestellung gedruckt Neuware - Printed after ordering - Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.…
Seller Inventory # 9780081028247
- Title
- Specification of Drug Substances and Products : Development and Validation of Analytical Methods
- Author
- Christopher M. Riley
- Publisher
- Elsevier Inc
- Publication year
- 2020
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 0081028245
- ISBN 13
- 9780081028247
- Edition
- 2nd Edition
- Item weight
- 1,370 grams
- Dimensions
- 240x195x38 mm
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.
The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
- Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
- Written by subject-matter experts involved in the development and application of the guidelines
- Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
- Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
"Synopsis" may belong to another edition of this title.
About the Author
Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor’s degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms.
Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.
"About the title" may belong to another edition of this title.
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