Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - Scientific guideline

This document addresses the use of pharmacokinetic-pharmacodynamic analyses to identify potentially eficacious dose regimens of antibacterial agents. It applies also to antimycobacterial and antifungal agents.

Keywords: Epidemiologic cut-off value, exposure-response relationship, minimal inhibitory concentration, pharmacokinetic-pharmacodynamic index, magnitude, target, probability of target attainment, wild-type distribution

Document history - Revision 1 (current)


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