Christopher M. Riley,
K. Lien Nguyen,
Lien Nguyen
Elsevier Science
e druk, 2024
9780443134661
Specification of Drug Substances and Products
Development and Validation of Analytical Methods
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
e druk, 2024
ISBN13: 9780443134661
Rubricering
Levertijd ongeveer 8 werkdagen
Samenvatting
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the second edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.
Specificaties
Inhoudsopgave
<p>Section I Introduction<br>1. Introduction<br>Section II Regulatory considerations and statistical approaches<br>2. Principles for setting specifications and shelf lives<br>3. Stability studies: General regulatory considerations and regional differences<br>4. Kinetics and mechanisms of drug degradation<br>5. Analytical procedure life cycle management<br>6. Process analytical technology<br>7. Pharmacopeial methods and tests<br>8. Development of United States Pharmacopeia-National Formulary (USPeNF) Monographs and General Chapters<br>9. The distinctiveness of the British Pharmacopeia and its relationship to other Pharmacopeia<br>10. Specifications and analytical procedures in registration applications<br>11. Specifications and analytical proceduresin clinical trial applications<br>Section III Critical quality attributes<br>12. Description and identification Ernest Parente<br>13. Assay and impurities: Specifications of new chemical entities (“small molecules”)<br>14. Assay and impurities: Method development as part of analytical life-cycle management<br>15. Assay and impurities: Method validation<br>16. Mutagenic impurities<br>17. Residual solvents<br>18. Elemental and inorganic impurities<br>19. Extractables and leachables<br>20. Microbiology methods<br>21. Solid-state methods: An overview<br>22. Solid-state characterization e Method development and validation<br>23. Chiral methods<br>24. Water determination<br>Section IV Dosage forms and product types<br>25. Orally administered dosage forms<br>26. Drug release: Topical products<br>27. Transdermal products<br>28. Inhalation products<br>29. Ophthalmic products<br>30. General analytical considerations for parenteral products<br>31. Specification of biotechnology products including cell and gene therapy<br>32. Biotechnology products: Validation of analytical methods<br>33. Biosimilars<br>34. Antibody-drug conjugates<br>35. Oligonucleotides<br>36. Specifications for vaccines<br>37. Nanoparticle suspension dosage forms by nanomilling<br>38. Development of connected drug delivery systems<br>Section V Biological fluids<br>39. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection<br>40. Bioanalysis of oligonuceotides<br> </p>