Goals, Design, Timing, and Future Opportunities for Nonclinical Drug Metabolism Studies

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Abstract
The nonclinical ADME (adsorption, distribution, metabolism, and excretion) studies employed during drug development are dependent on the regulatory expectations and the changing development focus from nonclinical to clinical issues. These evolving issues necessitate that the development goals for ADME studies also change during the development process. The rationale for these goal changes and their impact on the timing and design of the ADME studies are discussed in the context of drug development at Glaxo Inc. The progress in the technology and knowledge in drug metabolism and in biology provide new opportunities for pharmaceutical companies in predicting drug toxicities relevant to humans. Two case examples are discussed to illustrate this opportunity.