Clinical efficacy and safety: clinical pharmacology and pharmacokinetics

The European Medicines Agency's scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see: Public consultations.

Finalised guidelines

Bioanalytical method validation

Clinical investigation of the pharmacokinetics of therapeutic proteins

Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract

Clinical requirements for locally applied, locally acting products containing known constituents

Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function

Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Investigation of bioequivalence

Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1

Investigation of drug interactions

Pharmacokinetic and clinical evaluation of modified-release dosage forms

Pharmacokinetic studies in man

Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Reporting the results of population pharmacokinetic analyses

Role of pharmacokinetics in the development of medicinal products in the paediatric population

Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products

Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Clinical efficacy and safety: clinical pharmacology and pharmacokinetics

Points to consider

Reflection papers

Question and answer (Q&A) documents

Related content

Contact point

How useful was this page?