Clinical pharmacology and pharmacokinetics: questions and answers

The questions and answers (Q&As) on this page provide an overview of the European Medicines Agency's (EMA) position on specific issues related to clinical pharmacology and pharmacokinetics.

Users should read the Q&As in conjunction with the relevant scientific guidelines.

The Committee for Medicinal Products for Human Use (CHMP) may seek the input of the Pharmacokinetics Working Party (PKWP) to address specific questions in relation to clinical pharmacology. This input may contain general guidance or clarify specific aspects of scientific guidelines. EMA publishes the PKWP's input on this page.


The date refers to when the Q&A was first published.

Contact point

Questions about clinical pharmacology, activities of the PKWP and other general enquiries: Send a question to the European Medicines Agency.

For comments on guidelines under public consultation: Please complete the Microsoft Office document iconform for submission of comments on scientific guidelines and email it to pkwpsecretariat@ema.europa.eu.

Related content

Related documents

1. Pharmacokinetics

2. Drug interactions

3. Bioequivalence (general)

4. Product-specific bioequivalence

5. Bioequivalence in special populations

6. Biowaivers

7. Biosimilars

8. Modified release products

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