Clinical pharmacology and pharmacokinetics 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

Points to consider

• Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products

Concept papers

• Concept paper on the development of a Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development

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

Questions and answers

• The adequacy of the Mahalanobis distance to assess the comparability of drug dissolution profiles