ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/384/95
Published30/11/1994
Effective from01/06/1995
KeywordsToxicokinetics, systemic exposure, toxicology studies, concomitant toxicokinetics, study design
DescriptionThis document provides an understanding of the meaning and application of toxicokinetics and guidance on developing test strategies in toxicokinetics. It highlights the need to integrate pharmacokinetics into toxicity testing. Read together with the questions and answers.


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