Description
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 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).
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
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