Preclinical Drug Development

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.