Preclinical Drug Development 1/e

(Drugs and the Pharmaceutical Sciences Vol. 152 )

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



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.