The European Medicines Agency’s (EMA) scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers prepare marketing authorisation applications for human medicines.
If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.
A questions-and-answers document is available on specific questions addressed to the Pharmacokinetic Working Party (PKWP) in relation to pharmacokinetic evaluations, which should be read in conjunction with the relevant scientific guidelines:
- Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party
Points to consider
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