Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals.
There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines.
This 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 2nd 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 combinationproducts 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).
Auflage
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Techn.
Dateigröße
ISBN-13
978-0-443-13467-8 (9780443134678)
Schweitzer Klassifikation
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
