Clinical efficacy and safety: clinical pharmacology and pharmacokinetics
The European Medicines Agency's scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see: Public consultations.
Finalised guidelines
Points to consider
Reflection papers
Question and answer (Q&A) documents
Questions about clinical pharmacology, activities of the PKWP and other general enquiries:.
Comments on guidelines under public consultation: Please complete the
form for submission of comments on scientific guidelines
and email it to pkwpsecretariat@ema.europa.eu.