An edition of Early drug development
(2010)
Early drug development
strategies and routes to first-in-human trials
by Mitchell N. Cayen
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1
Early Drug Development: Strategies and Routes to First-In-Human Trials
2011, Wiley & Sons, Incorporated, John
in English
1118035208 9781118035207
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2
Early Drug Development: Strategies and Routes to First-In-Human Trials
2011, Wiley & Sons, Incorporated, John
in English
1118124804 9781118124802
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3
Early drug development: strategies and routes to first-in-human trials
2010, Wiley
in English
0470170867 9780470170861
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4
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5
Early Drug Development: Strategies and Routes to First-In-Human Trials
2010, Wiley & Sons, Incorporated, John
in English
0470613173 9780470613177
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6
Early Drug Development: Strategies and Routes to First-In-Human Trials
2010, Wiley & Sons, Incorporated, John
in English
047061319X 9780470613191
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Book Details
Table of Contents
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
Preclinical safety pharmacology studies recommended for supporting first-in-human (FIH) 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 Tonelli
Good laboratory practices / Anthony B. Jones, Kathryn Hackett-Fields, and Shari L. Perlstein
Estimation of starting dose for phase I clinical programs / Lorrene A. Buckley ... [et al.]
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 Sommer ... [et al.].
Edition Notes
Includes bibliographical references.
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| September 16, 2021 | Edited by ImportBot | import existing book |
| December 23, 2020 | Edited by MARC Bot | import existing book |
| July 29, 2011 | Created by LC Bot | import new book |