Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - Scientific guideline
Human
Scientific guidelines
This document considers the implication of pharmacokinetics/pharmacodynamics relationship for the development of antibacterial medicinal products.
Keywords: Pharmacokinetics (PK), pharmacodynamics (PD), PK/PD model, antibacterial medicinal product
Current effective version
Related content
- Clinical efficacy and safety: clinical pharmacology and pharmacokinetics
Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party- ICH E4 Dose response information to support drug registration
- Investigation of bioequivalence
- Pharmacokinetic studies in man