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 - Scientific guideline
- Clinical investigation of the pharmacokinetics of therapeutic proteins - Scientific guideline
- Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline
- Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function - Scientific guideline
- Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function - Scientific guideline
- Investigation of bioequivalence - Scientific guideline
- Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1 - Scientific guideline
- Investigation of drug interactions - Scientific guideline
- Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline
- Pharmacokinetic studies in man - Scientific guideline
- Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation - Scientific guideline
- Reporting the results of population pharmacokinetic analyses - Scientific guideline
- Role of pharmacokinetics in the development of medicinal products in the paediatric population - Scientific guideline
- Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Scientific guideline
- Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products - Scientific guideline
Points to consider
Reflection papers
- Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population - Scientific guideline
- Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Scientific guideline
- Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Scientific guideline
- Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product - Scientific guideline
Question and answer (Q&A) documents