This guideline replaces the ‘Points to consider’ on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99). The Guideline has been developed to outline the regulatory expectations for application dossiers and reflects both the scientific advances in the field of pharmacometrics that have implications for antimicrobial agent development programmes and the regulatory experience since the adoption of the ‘Points to consider’.

 

Posted on the EMA website on 28 September 2015