EMA issues guidance on PK/PD data in antibiotics development

EMA issued draft guidance on the use of pharmacokinetics and pharmacodynamics analyses to support the development of new antibiotics and the addition or amendment of dose recommendations for approved antibiotics.

EMA said PK/PD analyses have the potential to reduce or replace the need for dose-finding studies, though they will not replace the need for clinical efficacy data. PK/PD data may also be used to identify the need for dose modifications in certain subsets of patients, identify dose regimens that reduce the risk of selecting for antibiotic resistance, and support adaptive trial designs and biomarker validation studies. ...