| ISBN13: | 9780443134661 |
| ISBN10: | 0443134669 |
| Kötéstípus: | Puhakötés |
| Terjedelem: | 908 oldal |
| Méret: | 276x216 mm |
| Súly: | 1000 g |
| Nyelv: | angol |
| 657 |
Specification of Drug Substances and Products
EUR 240.00
Kattintson ide a feliratkozáshoz
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.
- Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions.
- Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug-device combination
products such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).
Section I Introduction
1. Introduction
Section II Regulatory considerations and statistical approaches
2. Principles for setting specifications and shelf lives
3. Stability studies: General regulatory considerations and regional differences
4. Kinetics and mechanisms of drug degradation
5. Analytical procedure life cycle management
6. Process analytical technology
7. Pharmacopeial methods and tests
8. Development of United States Pharmacopeia-National Formulary (USPeNF) Monographs and General Chapters
9. The distinctiveness of the British Pharmacopeia and its relationship to other Pharmacopeia
10. Specifications and analytical procedures in registration applications
11. Specifications and analytical proceduresin clinical trial applications
Section III Critical quality attributes
12. Description and identification Ernest Parente
13. Assay and impurities: Specifications of new chemical entities (“small molecules”)
14. Assay and impurities: Method development as part of analytical life-cycle management
15. Assay and impurities: Method validation
16. Mutagenic impurities
17. Residual solvents
18. Elemental and inorganic impurities
19. Extractables and leachables
20. Microbiology methods
21. Solid-state methods: An overview
22. Solid-state characterization e Method development and validation
23. Chiral methods
24. Water determination
Section IV Dosage forms and product types
25. Orally administered dosage forms
26. Drug release: Topical products
27. Transdermal products
28. Inhalation products
29. Ophthalmic products
30. General analytical considerations for parenteral products
31. Specification of biotechnology products including cell and gene therapy
32. Biotechnology products: Validation of analytical methods
33. Biosimilars
34. Antibody-drug conjugates
35. Oligonucleotides
36. Specifications for vaccines
37. Nanoparticle suspension dosage forms by nanomilling
38. Development of connected drug delivery systems
Section V Biological fluids
39. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection
40. Bioanalysis of oligonuceotides