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

PART 1 INTRODUCTION 1. Introduction 2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting 3. General Principles and Regulatory Considerations: Method Development and Validation 4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 5. Analytical Methods in the Clinical Phase of Development 6. Method Transfer 7. Process Analytical Technology

PART 2 UNIVERSAL TESTS 8. Description and Identification 9. Assay and Impurities: Specifications 10. Assay and Impurities: Method Development and Life-Cycle Management 11. Assay and Impurities: Method Validation 12. Mutagenic 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. Extractables and Leachables

PART 5 BIOTECHNOLOGY PRODUCTS 21. Regulatory Requirements for Setting Drug Substance and Drug Product Specifications  22. Validation of Analytical Methods for Biotechnology Products

PART 6 PHARMACOPEIAL METHODS 23. Pharmacopeial Methods and Test (Updated)

PART 7 BIOLOGICAL FLUIDS 24. Biological Fluids