This document provides guidance on circumstances when repeated dose tissue distribution studies should be considered. It describes the design and conduct of such studies.

Keywords: Repeated dose tissue distribution studies, absorption, distribution, metabolism and elimination (ADME), metabolite

Current effective version

ICH: S 3 B: Pharmacokinetics: Guidance for repeated dose tissue distribution studies - Step 5

AdoptedLegal effective date: Reference Number: CPMP/ICH/385/95

English (EN) (115.69 KB - PDF)

First published: Last updated:
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