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 - Scientific guideline
- ICH S3B Pharmacokinetics: repeated dose tissue distribution studies - Scientific guideline
- Evaluation of control samples for non-clinical safety studies: checking for contamination with the test substance - Scientific guideline