Non-clinical: pharmacokinetics and toxicokinetics

The European Medicines Agency's scientific guidelines on non-clinical pharmacokinetics and toxicokinetics help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

• ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies
• ICH S3B Pharmacokinetics: repeated dose tissue distribution studies
• Evaluation of control samples for non-clinical safety studies: checking for contamination with the test substance - Scientific guideline