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...
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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.
In the EC, US and Japan, there has been a general agreement on the need to
conduct single dose tissue distribution studies as part of the non-clinical
programme.
These studies often provide sufficient information about tissue
distribution.
There has been no consistent requirement for repeated dose tissue distribution
studies.
However, there may be circumstances when assessments after repeated
dosing may yield important information.
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