Specification of Drug Substances and Products: Development and Validation of Analytical Methods - Hardcover

Über die Autorinnen und Autoren

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.

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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 authorities

• Includes extensive information on Residual Solvents, Inorganic impurities, Solid-state characterization, Chiral Methods, Extractables and Leachables, Pharmacopeial Methods and Tests, and more.

Christopher M. Riley is President of Riley and Rabel Consulting Services. He was Vice President of Analytical R&D at DuPont Pharmaceutical Company, and Vice President of ChemPharm at ALZA (a division of Johnson and Johnson) as well as a member of the ICH Expert Working Group on Impurities.

Thomas W. Rosanske is the 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.

Shelley R. Rabel Riley is an Assistant Professor of Chemistry in the Department of Natural Sciences at Northwest Missouri State University, as well as Vice-President of Riley and Rabel Consulting Services. She has previously held Principal Scientist positions at DuPont Pharmaceutical Company and ALZA (a division of Johnson and Johnson), and served as Director of Small Molecule Pharmaceutics at Amgen.