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Full Description
Specification of Drug Substances and Productsof 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.
Contents
Part OnePrinciples 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 ValidationPart 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 DeterminationPart Four: Specific Tests: Drug Products 12. Dissolution and Disintegration 13. Extractables and Leachables 14. Potency Assays for Biomolecules 15. Host Cell Protein AssaysPart Five: Pharmacopeial Methods 16. Pharmacopeial Methods and TestsPart Six: Microbial Methods 17. Sterile and Non-Sterile ProductsPart Seven: Biological Fluids 18. Biological Fluids
