Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered-or not substantially covered-in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification settingWritten by subject-matter experts involved in the development and application of the guidelinesProvides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and productsCovers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction INDICE: PART 1 INTRODUCTION 1. Introduction 2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting 3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 4. General Principles and Regulatory Considerations: Method Development and Validation 5. Analytical Methods in the Clinical Phase of Development Chapter 6 Method Transfer 7. Process Analytical Technology 8. Analytical Procedure Life Cycle Management 9. Challenges of Analytics in Generic Products PART 2 UNIVERSAL TESTS 10. Description and Identification 11. Assay and Impurities 12. Genotoxic Impurities 13. Residual Solvents 14. Inorganic Impurities (Elemental Impurities) PART 3 SPECIFIC TESTS: DRUG SUBSTANCES 15. Solid State Characterization 16. Chiral Methods 17. Water Determination PART 4 SPECIFIC TESTS DRUG PRODUCT 18. Drug Release: Oral Products 19. Topical Products 20. Nasal Sprays and Inhalation Products 21. Extractables and Leachables PART 5 BIOTECHNOLOGY PRODUCTS 22. Regulatory Requirements for Setting Specifications 23. Specifications for Drug Substance 24. Specifications for Drug Product 25. Validation of Analytical Methods 26. Complex Biological Products PART 6 PHARMACOPEIAL METHODS 27. Pharmacopeial Methods and Test PART 7 BIOLOGICAL FLUIDS 28. Biological Fluids PART 8 STERILE PRODUCTS 29. Microbial Methods and Endotoxin Testing

• ISBN: 978-0-08-102824-7
• Editorial: Elsevier
• Encuadernacion: Rústica
• Páginas: 712
• Fecha Publicación: 01/08/2019
• Nº Volúmenes: 1
• Idioma: Inglés