HPLC Method Development for Pharmaceuticals
Separation Science and Technology Series, Vol. 8
Coordinators: Ahuja Satinder, Rasmussen HenrikLanguage: Anglais
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510 p. · 16.5x24 cm · Hardback
HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.
* Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
* Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
* Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase
2. HPLC Theory (Y.V. Kazakevich).
3. HPLC Columns and Packings (U.D. Neue et al.).
4. Column Characterization and Selection (D. Visky).
5. Chiral Separations (Xiande Wang et al.).
6. Contemporary Liquid Chromatographic Systems for Method Development (M. Swartz).
7. Hyphenated Techniques (D.L. Norwood et al.).
8. HPLC Sample Preparation (G. Slack, N.H. Snow).
9. Instrument and Software Qualification and Validation (D. Van Geel).
10. Pharmaceutical Development: From Pre-clinical to Post Approval (K. Bynum).
11. HPLC Method Development for Drug Discovery LC-MS Assays in Rapid PK Applications (Xiaoying Xu, W. Korfmacher).
12. HPLC Method Development in Early Phase Pharmaceutical Development (H.T. Rasmussen et al.).
13. HPLC Method Development in Late Phase Pharmaceutical Development (M. Ilias Jimidar).
14. Use of HPLC for In-process Testing (C. Richardson).
15. Method Development for Biomolecules (D.E. Raynie, J.L. Driver).
16. Method Validation (M. Ilias Jimidar et al.).
17. Troubleshooting HPLC Methods (H. McNair).
18. Molecularly Imprinted Polymers as Sorbents for Separations and Extractions (M.T. Koesdjojo et al.).