| Description |
xi, 382 pages : illustrations + 1 CD-ROM (4 3/4 in.). |
| Bibliography |
Includes bibliographical references and index. |
| Contents |
Health care and industry overview and challenges / Ronald P. Evens -- R&D planning and governance / Ronald P. Evens and Joel Covinsky -- R&D outcomes / Ronald P. Evens -- Discovery and nonclinical development / Stephen F. Carroll -- Types of clinical studies / Lewis J. Smith -- Metabolism and pharmacokinetics / Jun Shi, Shashank Rohatagi, and Vijay O. Bhargava -- Laws and regulations : the discipline of regulatory affairs / Elaine S. Waller and Nancy L. Kercher -- Clinical trial operations / Carl L. Roland and Paul Litka -- Formulation and manufacturing / Leo Pavliv and James F. Cahill -- Commercial division / Thomas Lytle -- Medical affairs and professional services / Ronald P. Evens -- Special considerations in research. Cardiovascular drug development / C. Michael White, Jessica Song, and Jeffrey Kluger -- Infectious diseases / Ralph H. Raasch -- Oncology / Suzanne F. Jones and Howard A. Burris III -- Pediatrics / Philip D. Walson -- Psychiatry / Michael W. Jann, John J. Brennan, and Roland Garritsen VanderHoop. |
| System Details |
System requirements: Microsoft Powerpoint. |
| Subject |
Drug Evaluation.
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Drug Approval.
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Drug Industry -- organization & administration.
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Product Surveillance, Postmarketing.
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Drug development.
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Biotechnology -- Research.
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New products.
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| Added Author |
Evans, Ronald P.
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| ISBN |
9780387329789 hardback alkaline paper |
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0387329781 hardback alkaline paper |
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9780387690940 (e-ISBN) |
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0387690948 (e-ISBN) |
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