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.
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Table of Contents
Section I Introduction 1. Introduction Section II Regulatory considerations and statistical approaches 2. Principles for setting specifications and shelf lives 3. Stability studies: General regulatory considerations and regional differences 4. Kinetics and mechanisms of drug degradation 5. Analytical procedure life cycle management 6. Process analytical technology 7. Pharmacopeial methods and tests 8. Development of United States Pharmacopeia-National Formulary (USPeNF) Monographs and General Chapters 9. The distinctiveness of the British Pharmacopeia and its relationship to other Pharmacopeia 10. Specifications and analytical procedures in registration applications 11. Specifications and analytical proceduresin clinical trial applications Section III Critical quality attributes 12. Description and identification Ernest Parente 13. Assay and impurities: Specifications of new chemical entities (“small molecules”) 14. Assay and impurities: Method development as part of analytical life-cycle management 15. Assay and impurities: Method validation 16. Mutagenic impurities 17. Residual solvents 18. Elemental and inorganic impurities 19. Extractables and leachables 20. Microbiology methods 21. Solid-state methods: An overview 22. Solid-state characterization e Method development and validation 23. Chiral methods 24. Water determination Section IV Dosage forms and product types 25. Orally administered dosage forms 26. Drug release: Topical products 27. Transdermal products 28. Inhalation products 29. Ophthalmic products 30. General analytical considerations for parenteral products 31. Specification of biotechnology products including cell and gene therapy 32. Biotechnology products: Validation of analytical methods 33. Biosimilars 34. Antibody-drug conjugates 35. Oligonucleotides 36. Specifications for vaccines 37. Nanoparticle suspension dosage forms by nanomilling 38. Development of connected drug delivery systems Section V Biological fluids 39. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection 40. Bioanalysis of oligonuceotides
Authors
Christopher M. Riley President of Riley and Rabel Consulting Services, Maryville, MO, USA.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.
K. Lien Nguyen Head of Chemistry, Manufacturing and Controls at IRL AB, Sweden. 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.
