S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

Regulatory Resource: S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in October 1994. This document gives guidance on developing test strategies in toxicokinetics and the need to integrate pharmacokinetics into toxicity testing, in order to aid in the interpretation of the toxicology findings and promote rational study design development.

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