Preclinical drug development/edited by Mark C. Rogge, David R. Taft.
2nd ed. 2010 by Informa Healthcare USA, Inc.
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Contents:
Preface . . . . vii
Contributors . . . . xi
1. The Scope of Preclinical Drug Development: An Introduction and Framework 1
Mark C. Rogge
2. Lead Molecule Selection: Pharmaceutical Profiling and Toxicity Assessments 7
P. L. Bullock
3. Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical
Data to Human Populations 35
M. N. Martinez
4. Pharmacokinetics/ADME of Small Molecules 71
A. D. Ajavon and David R. Taft
5. Pharmacokinetics/ADME of Large Molecules 117
R. Braeckman
6. Preclinical Pharmacokinetic–Pharmacodynamic Modeling and Simulation in Drug
Development 142
P. L. Bonate and P. Vicini
7. Formulation and Production Strategies for Enhancing Bioavailability of Poorly
Absorbed Drugs 161
A. B. Watts and R. O. Williams III
8. Transporters Involved in Drug Disposition, Toxicity, and Efficacy 196
C. Q. Xia and G. T. Miwa
9. Toxicity Evaluations, ICH Guidelines, and Current Practice 231
J. L. Larson
10. Application of Pathology in Safety Assessment 271
Robert A. Ettlin and David E. Prentice
11. Utilizing the Preclinical Database to Support Clinical Drug Development 336
H. Lee
Index . . . . 349
Preclinical drug development/edited by Mark C. Rogge, David R. Taft.—2nd ed.
(Drugs and the pharmaceutical sciences; 187)
1. Drug development. I. Rogge, Mark C.
II. Taft, David R. III. Series: Drugs and the pharmaceutical sciences; v. 187.
[DNLM: 1. Drug Evaluation, Preclinical – methods. 2. Drug Industry – methods.
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