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
- 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 and early clinical trials with investigational medicinal products
- Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
Points to consider
Reflection papers
- Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population
- Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product
- Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product
- Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product
Question and answer (Q&A) documents