Specification of Drug Substances and Products

Development and Validation of Analytical Methods

Häftad, Engelska, 2024

2 554 kr

Beställningsvara. Skickas inom 10-15 vardagar. Fri frakt över 249 kr.

Beskrivning

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).

Produktinformation

Utgivningsdatum:2024-09-25
Mått:216 x 276 x undefined mm
Vikt:1 000 g
Format:Häftad
Språk:Engelska
Antal sidor:908
Upplaga:3
Förlag:Elsevier Science
ISBN:9780443134661

Utforska kategorier

Analytisk kemi inom Naturvetenskap och teknik

Mer om författaren

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.

Innehållsförteckning

Section I Introduction1. IntroductionSection II Regulatory considerations and statistical approaches2. Principles for setting specifications and shelf lives3. Stability studies: General regulatory considerations and regional differences4. Kinetics and mechanisms of drug degradation5. Analytical procedure life cycle management6. Process analytical technology7. Pharmacopeial methods and tests8. Development of United States Pharmacopeia-National Formulary (USPeNF) Monographs and General Chapters9. The distinctiveness of the British Pharmacopeia and its relationship to other Pharmacopeia10. Specifications and analytical procedures in registration applications11. Specifications and analytical proceduresin clinical trial applicationsSection III Critical quality attributes12. Description and identification Ernest Parente13. Assay and impurities: Specifications of new chemical entities (“small molecules”)14. Assay and impurities: Method development as part of analytical life-cycle management15. Assay and impurities: Method validation16. Mutagenic impurities17. Residual solvents18. Elemental and inorganic impurities19. Extractables and leachables20. Microbiology methods21. Solid-state methods: An overview22. Solid-state characterization e Method development and validation23. Chiral methods24. Water determinationSection IV Dosage forms and product types25. Orally administered dosage forms26. Drug release: Topical products27. Transdermal products28. Inhalation products29. Ophthalmic products30. General analytical considerations for parenteral products31. Specification of biotechnology products including cell and gene therapy32. Biotechnology products: Validation of analytical methods33. Biosimilars34. Antibody-drug conjugates35. Oligonucleotides36. Specifications for vaccines37. Nanoparticle suspension dosage forms by nanomilling38. Development of connected drug delivery systemsSection V Biological fluids39. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection40. Bioanalysis of oligonuceotides