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Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approache… Read more
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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.
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
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