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Title Drug and biological development : from molecule to product and beyond / editor, Ronald P. Evens.

Publication Info. New York : Springer, [2007]


Location Call No. Status
 University of Saint Joseph: Pope Pius XII Library - Reference Material  PHARM QV 771 D794 2007    In-Library Use Only
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.
Drug Approval.
Drug Industry -- organization & administration.
Product Surveillance, Postmarketing.
Drug development.
Biotechnology -- Research.
New products.
Added Author Evans, Ronald P.
ISBN 9780387329789 hardback alkaline paper
0387329781 hardback alkaline paper
9780387690940 (e-ISBN)
0387690948 (e-ISBN)
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