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

Softcover

ISBN 10: 0443134669 ISBN 13: 9780443134661

Publisher: Elsevier, 2024

Synopsis

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the second edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.

• Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions.
• Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination
  products such as digital drug delivery systems, transdermal systems, and inhalation products.
• Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).

About this title

About the Authors

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.

Dr. Nguyen is Head of Chemistry, Manufacturing and Controls at IRL AB in Sweden. She received a Bachelor of Chemical Engineering from University of Adelaide, Australia (2003) and Ph.D. in Chemical Engineering from University of Cambridge, UK (2007). She worked at GlaxoSmithKline (UK), AstraZeneca (Sweden) and Savara Pharmaceuticals (Denmark) in various roles across pharmaceutical development. She has extensive experience in the development of all types of dosage forms in general, and inhalation products in particular.

From the Back Cover

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a fully comprehensive reference on specification setting for pharmaceuticals. The revisions and increased scope of this edition reflect changes in the regional and international regulations and guidelines, which have resulted in or have been driven by changes in approaches to the specification of new drug substances and new drug products.
Some of the notable changes are the increased emphasis on the importance of the analytical target profile, analytical procedure life-cycle management, and continuous method improvement. New topics include regional differences in quality requirements compared with those recommended by the International Council on Harmonization (ICH) (notably revision of the validation guideline, Q2, and publication of a new guideline Q14 Analytical Procedure Development). New chapters include pharmacopeial recommendations, the analytical content of application for clinical trials, marketing authorization applications, an additional chapter on solid-state methods, and chapters on specific dosage forms containing orally administered products, topicals, transdermals, inhalation products, ophthalmics, parenterals, nanoparticles, biosimilars, antibodies and drug–antibody conjugates, oligonucleotides, vaccines, and connected drug–devices combination products. The bioanalysis chapter has been supplemented by a separate chapter on the bioanalysis of nucleotides.
This substantially expanded revision of the 2nd edition will serve as a practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.

Edition details

• Publisher: Elsevier
• Publication date: 2024
• Language: English
• ISBN 10: 0443134669
• ISBN 13: 9780443134661
• Binding: Paperback
• Edition number: 3
• Number of pages: 908
• Editor: Riley PhD Christopher M., Nguyen Ph.D K. Lien