Clinical pharmacology and pharmacokinetics
Human
Regulatory and procedural guidance
Scientific guidelines
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
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 iron-based nano-colloidal products developed with reference to an innovator medicinal product