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 Methodology Working Party (MWP) to address specific questions in relation to clinical pharmacology and pharmacokinetics. This input may contain general guidance or clarify specific aspects of scientific guidelines and product-specific bioequivalence guidance.

The date after each question refers to when it was first published. Several Q&As refer to the PKWP (Pharmacokinetics Working Party), whose activities have been taken over in 2022 by the MWP.

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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