Preclinical Drug Development, Second Edition
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.June 1, 2000. 6. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition. ... Japanese Guidelines for Nonclinical Studies of Drugs Manual. Tokyo, Japan: Yakuji ... Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities. Draft Guidance.
| Title | : | Preclinical Drug Development, Second Edition |
| Author | : | Mark Rogge, David R. Taft |
| Publisher | : | CRC Press - 2009-09-25 |
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