Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Thomas W. Rosanske, George L. Reid.  (Text) (Text)

Riley, Christopher M | Rosanske, Thomas W | Reid, George L
Call no.: QV55 .S64 2020Publication: Amsterdam : Elsevier, c2020Edition: 2nd edDescription: xii, 682 p. : col. illISBN: 9780081028247; 0081028245Subject(s): Pharmaceutical preparations -- StandardsDrug development
Contents:I Introduction -- 1. Introduction -- 2. General principles and regulatory condiderations: specifications and shelf life setting -- 3. General principles and regulatory condiderations: method validation -- 4. Application of quality by design to the development and validation of analytical methods -- 5. Analytical method in the clinical phase of development -- 6. Analytical method transfer -- 7. Process analytical technology -- II Universal tests -- 8. Description and identification -- 9. Assay and impurities: specifications -- 10. Assay and impurities: method development as part of analytical life cycle management -- 11. Assay and impurities: method validation -- 12. Mutagenic impurities -- 13. Residual solvents -- 14. Elemental and inorganic impurities -- III Specific tests: drug substances -- 15. Solid-state characterization-method development and validation -- 16. Chiral methods -- 17. Water determination -- IV Specific tests: Drug product -- 18. Dissolution -- 19. Drug release: topical products -- 20. Extractables and leachables -- V. Biotechnology products -- 21. Specification of biotechnology products -- 22. Biotechnology products: validation of analytical methods -- VI Pharmacopeial methods -- 23. Pharmacopeial methods and tests -- VII Biological fluids -- 24. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection.
แสดงรายการนี้ใน: TUMED-New Books 2020-December (Foreign)
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Book Book Nongyao Chaiseri Library
General Stacks QV55 .S64 2020 (เรียกดูชั้นหนังสือ) ยืมออก 31/08/2021 31379016222284
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Includes bibliographical references and index.

I Introduction -- 1. Introduction -- 2. General principles and regulatory condiderations: specifications and shelf life setting -- 3. General principles and regulatory condiderations: method validation -- 4. Application of quality by design to the development and validation of analytical methods -- 5. Analytical method in the clinical phase of development -- 6. Analytical method transfer -- 7. Process analytical technology -- II Universal tests -- 8. Description and identification -- 9. Assay and impurities: specifications -- 10. Assay and impurities: method development as part of analytical life cycle management -- 11. Assay and impurities: method validation -- 12. Mutagenic impurities -- 13. Residual solvents -- 14. Elemental and inorganic impurities -- III Specific tests: drug substances -- 15. Solid-state characterization-method development and validation -- 16. Chiral methods -- 17. Water determination -- IV Specific tests: Drug product -- 18. Dissolution -- 19. Drug release: topical products -- 20. Extractables and leachables -- V. Biotechnology products -- 21. Specification of biotechnology products -- 22. Biotechnology products: validation of analytical methods -- VI Pharmacopeial methods -- 23. Pharmacopeial methods and tests -- VII Biological fluids -- 24. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection.

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