Looking for DMPK-related regulatory guidance documents?

Here are links to key regulatory guidance documents related to DMPK which are important to consider at the drug discovery & development stages.

M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (FDA, 2010)

M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers (FDA, 2013)

Safety Testing of Drug Metabolites (MIST) (FDA, 2020)

M12 Drug Interaction Studies (Draft ICH document on FDA’s website; 2022)

Drug Interactions: Relevant Regulatory Guidance and Policy Documents by the FDA

Guideline on the investigation of drug interactions (EMA, 2012)

S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (ICH, 1994)

S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (ICH, 1994)

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (FDA, 2010)

Repository of all ICH multidisciplinary guidelines