This reference discusses in detail the broad realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology through the regulatory expectations that support clinical trials. Providing chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling, this guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.
Features
This timely and informative reference discusses
· the elements of drug development with emphasis on understanding mechanisms and outcomes
· ICH preclinical guidelines that regulate the entry into human trials and continuation of human trials as development progresses
· aspects of animal models and genetically altered species
· case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development
· experimental methods used to study membrane drug transport and metabolism
· gross and microscopic evaluations that elucidate the safety profile of a drug candidate
· pharmacogenetic technology that will become a mainstream component of drug development
· the utilization of the preclinical database to support clinical drug development
· the limitations and predictive value of the preclinical database