| Description |
1 online resource (xvii, 452 pages) : illustrations |
| Contents |
Excipients : background/introduction / Lokesh Bhattacharyya, Stefan Schuber, Catherine Sheehan, Roger William -- Food and drug administration perspective on regulation of pharmaceutical excipients / Harold Davis -- Pharmaceutical excipient development -- a preclinical challenge / Paul Baldrick -- Regulation of pharmaceutical excipients / Robert G. Pinco, Theodore M. Sullivan -- Cyclodextrins -- enabling excipients : a case study of the development of a new excipient -- sulfobutylether (beta)-cyclodextrin (CAPTISOL) / Diane O. Thompson -- The use of food additive safety evaluation procedures as a basis for evaluating the safety of new pharmaceutical excipients / Christopher C. DeMerlis, Julia C. Howell -- Pharmacopeial harmonization / J. Lane, Catherine Sheehan -- Excipient interactions / R. Christian Moreton -- Improved excipient functionality by coprocessing / Piyush Gupta, Satish K. Nachaegari, Arvind K. Bansal -- A comparison of physical and mechanical properties of common tableting diluents / Glenn T. Carlson, Bruno C. Hancock -- Excipients for oral liquid formulations / Meagan Anderson, F. Opawale, M. Rao, D. Delmarre, Gopal Anyarambhatla -- Use of nonactive pharmaceutical excipients in oral drug formulations : biopharmaceutical classification system considerations / Jane P.F. Bai, Jian-Hwa Guo, Mahesh V. Chaubal -- Excipients for semisolid formulations Prashant Srivastava -- Excipients for pulmonary formulations / Hugh Smyth -- Synergistic combinations of penetration enhancers and their discovery by high-throughput screening / Pankaj Karande, Amit Jain, Samir Mitragotri -- Excipient selection and criteria for injectable dosage forms / Mahesh V. Chaubal, James Kipp, Barrett Rabinow -- Excipients for protein drugs / Yatin R. Gokarn [and others] -- Excipients used in vaccines / Manmohan Singh, Derek O'Hagan -- Polymeric excipients for controlled release applications / Mahesh V. Chaubal -- Emerging excipients in parenteral medications : the new paradigm / Shireesh P. Apte, Sydney O. Ugwu -- Excipient manufacturing and good manufacturing practices / Irwin Silverstein -- Excipient quality assurance : handling, sampling, and regulatory issues / Raafat Fahmy, Stephen W. Hong -- Excipient distribution / Victoria M. Shaheen |
| Summary |
Facilitates the development of novel drug delivery systems and biotechnology-oriented drugs. This book presents information on various aspects of excipient development and testing. It addresses specific details such as preclinical testing, safety and toxicology evaluation, as well as regulatory and quality aspects |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Excipients.
|
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Excipients -- chemistry
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Drug Approval
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Drug Evaluation
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Excipients -- pharmacokinetics
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Excipients
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Pharmaceutical Vehicles
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Excipients.
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| Form |
Electronic book
|
| Author |
Katdare, Ashok.
|
|
Chaubal, Mahesh Vijay, 1971-
|
| ISBN |
9781420004137 |
|
1420004131 |
|
0849327067 |
|
9780849327063 |
|
1280863099 |
|
9781280863097 |
|
