Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. - Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD) - Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities - Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

Part One: Basic Concepts and Definitions 1. Introduction 2. General Principles and Regulatory Considerations: Specifications 3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 4. General Principles and Regulatory Considerations: Method Validation

Part Two: Universal Tests 5. Description and Identification 6. Assay, and Impurities 7. Residual Solvents 8. Inorganic Impurities (Heavy Metals)

Part Three: Specific Tests: Drug Substances 9. Solid-State Characterization 10. Chiral Methods 11. Water Determination

Part Four: Specific Tests: Drug Products 12. Dissolution and Disintegration 13. Extractables and Leachables 14. Potency Assays for Biomolecules 15. Host Cell Protein Assays

Part Five: Pharmacopeial Methods 16. Pharmacopeial Methods and Tests

Part Six: Microbial Methods 17. Sterile and Non-Sterile Products

Part Seven: Biological Fluids 18. Biological Fluids