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HPLC Method Development for Pharmaceuticals[electronic resource].

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615/.1901
書名/作者:	HPLC Method Development for Pharmaceuticals
出版者:	: Academic Pr, 2007.
標題:	High performance liquid chromatography - Methodology.
標題:	Drugs - Analysis.
標題:	Drug development.
ISBN:	9780123705402
ISBN:	0123705401
內容註:	1. Overview (Satinder Ahuja). -- 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.).
摘要、提要註:	High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. 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.
電子資源:	http://www.sciencedirect.com/science/book/9780123705402

HPLC Method Development for Pharmaceuticals[electronic resource].
HPLC Method Development for Pharmaceuticals[electronic resource]. - Academic Pr2007.

1. Overview (Satinder Ahuja). -- 2. HPLC Theory (Y.V. Kazakevich). -- 3. HPLC Columns and Packings (U.D. Neue <IT>et al</IT>.). -- 4. Column Characterization and Selection (D. Visky). -- 5. Chiral Separations (Xiande Wang <IT>et al</IT>.). -- 6. Contemporary Liquid Chromatographic Systems for Method Development (M. Swartz). -- 7. Hyphenated Techniques (D.L. Norwood <IT>et al</IT>.). -- 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 <IT>et al</IT>.). -- 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 <IT>et al</IT>.). -- 17. Troubleshooting HPLC Methods (H. McNair). -- 18. Molecularly Imprinted Polymers as Sorbents for Separations and Extractions (M.T. Koesdjojo <IT>et al</IT>.).

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. 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.

Electronic reproduction.
Amsterdam :
Elsevier Science & Technology,
2007.

Mode of access: World Wide Web.

ISBN: 9780123705402

Source: 116045:116143Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

431430
High performance liquid chromatography
--Methodology.Index Terms--Genre/Form:

336502
Electronic books.

LC Class. No.: RS189.5.H54 / H65 2007

Dewey Class. No.: 615/.1901

HPLC Method Development for Pharmaceuticals[electronic resource].
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520 $a High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. 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.
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