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S3B - PharmaFacts
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Guidances - ICH Guidances

S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies:

The tripartite harmonised ICH guideline was finalised (Step 4) in October 1994. This document gives guidance on circumstances when repeated dose tissue distribution studies should be considered (i.e., when appropriate data cannot be derived from other sources). It also gives recommendations on the conduct of such studies.