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.
