| Document Type
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BL
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| Record Number
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1045836
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| Doc. No
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b800206
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| Title & Author
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Early drug development : : strategies and routes to first-in-human trials /\ edited by Mitchell N. Cayen.
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| Publication Statement
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Hoboken, N.J. :: Wiley,, ©2010.
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| Page. NO
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1 online resource (xxv, 630 pages) :: illustrations
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| ISBN
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0470170867
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: 0470613173
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: 047061319X
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: 9780470170861
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: 9780470613177
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: 9780470613191
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9780470170861
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Drug discovery and early drug development / Mitchell N. Cayen -- ADME strategies in lead optimization / Amin A. Nomeir -- Prediction of pharmacokinetics and drug safety in humans / Peter L. Bullock -- Bioanalytical strategies / Christopher Kemper -- Chemistry, manufacturing and controls : the drug substance and formulated drug product / Orn Almarsson and Christopher J. Galli -- Nonclinical safety pharmacology studies recommended for support of first-in-human clinical trials / Duane B. Lakings -- Toxicology program to support initiation of a clinical phase I program for a new medicine / Hugh E. Black, Stephen B. Montgomery, and Ronald W. Moch -- Toxicokinetics in support of drug development / Gary Eichenbaum, Vangala Subrahmanyam, and Alfred P. Tonelli -- Good laboratory practice / Anthony B. Jones, Kathryn Hackett-Fields, and Shari L. Perlstein -- Estimation of human starting dose for phase I clinical programs / Lorrene A. Buckley [and others] -- Exploratory INDS/CTAS / Mitchell N. Cayen -- Unique considerations for biopharmaceutics / Laura P. Andrews and James D. Green -- Project management and international regulatory requirements for first-in-human trials / Carolyn D. Finkle and Judith Atkins -- First-in-human regulatory submissions / Mary M. Sommer [and others].
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| Abstract
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The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support.
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| Subject
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Drug development.
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Clinical Trials, Phase I as Topic.
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Drug Approval-- organization administration.
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Drug Discovery-- methods.
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Drugs, Investigational-- therapeutic use.
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Research Design.
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Drug development.
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MEDICAL-- Drug Guides.
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MEDICAL-- Nursing-- Pharmacology.
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MEDICAL-- Pharmacology.
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MEDICAL-- Pharmacy.
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| Dewey Classification
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615/.19
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| LC Classification
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RM301.25.E27 2010eb
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| NLM classification
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QV 744E12 2010
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| Added Entry
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Cayen, Mitchell N.
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