Development and Validation of Analytical Methods, 2e (2nd edition)

Development and Validation of Analytical Methods, 2e (2nd edition)


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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.

About Author

President of Riley and Rabel Consulting Services. Former Vice President of Analytical R&D at DuPont Pharmaceutical Company, and Vice President of ChemPharm at ALZA (a division of Johnson and Johnson) as well as a member of the ICH Expert Working Group on Impurities. Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee. Assistant Professor of Chemistry in the Department of Natural Sciences at Northwest Missouri State University, as well as Vice-President of Riley and Rabel Consulting Services. She has previously held Principal Scientist positions at DuPont Pharmaceutical Company and ALZA (a division of Johnson and Johnson), and served as Director of Small Molecule Pharmaceutics at Amgen.


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

Product Details

  • ISBN13: 9780080983509
  • Format: Hardback
  • Number Of Pages: 390
  • ID: 9780080983509
  • ISBN10: 0080983502
  • edition: 2nd edition

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