Clinical efficacy and safety: Clinical pharmacology and pharmacokinetics

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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:


Points to consider

Reflection papers

Concept papers

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