著者紹介

目次

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