The European Medicines Agency’s scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers prepare marketing authorisation applications for human medicines.
For the specific questions on the pharmacokinetic evaluations addressed to the Pharmacokinetic Working Party, see:
- Questions and answers: positions on specific questions addressed to the Pharmacokinetics Working Party
If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Draft guidelines under public consultation
Points to consider
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