Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials.
Highlights of the Second Edition include:
- Pharmacokinetics
- Modeling and simulation
- Formulation and routes of administration
- Toxicity evaluations
- The assessment of drug absorption and metabolism
- Interspecies scaling
- Lead molecule selection and optimization via profiling
- Screening using in silico and in vitro toxicity evaluations
The book also includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.
The Scope of Preclinical Drug Development: An Introduction and Framework; Mark C. Rogge
Lead Molecule Selection: Pharmaceutical Profiling and Toxicity Assessments; P. L. Bullock
Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical
Data to Human Populations; M. N. Martinez
Pharmacokinetics/ADME of Small Molecules; A. D. Ajavon and David R. Taft
Pharmacokinetics/ADME of Large Molecules; R. Braeckman
Preclinical Pharmacokinetic–Pharmacodynamic Modeling and Simulation in Drug Development; P. L. Bonate and P. Vicini
Formulation and Production Strategies for Enhancing Bioavailability of Poorly Absorbed Drugs; A. B. Watts and R. O. Williams III
Transporters Involved in Drug Disposition, Toxicity, and Efficacy; C. Q. Xia and G. T. Miwa
Toxicity Evaluations, ICH Guidelines, and Current Practice; J. L. Larson
Application of Pathology in Safety Assessment; Robert A. Ettlin and David E. Prentice
Utilizing the Preclinical Database to Support Clinical Drug Development; H. Lee
Index
Biography
Mark Rogge, David R. Taft
'...an excellent book covering important aspects of preclinical drug development. All chapters are well-written...' - The British Toxicology Society Newsletter
