Issue Date: March 1, 1995
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
A comprehensive knowledge of the absorption, distribution, metabolism and elimination of a compound is important for the interpretation of pharmacology and toxicology studies. Tissue distribution studies are essential in providing information on distribution and accumulation of the compound and/or metabolites, especially in relation to potential sites of action; this information may be useful for designing toxicology and pharmacology studies and for interpreting the results of these experiments.
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