EMA Lays out Usage Guidelines for Analyzing Antimicrobials

The EMA is advising drugmakers to rely on two types of analyses — metabolic and mechanism of action — to determine the minimum effective dosage for antimicrobial drugs. 

In a final guideline released, the agency spells out how drugmakers can use microbiological data to reduce or eliminate the need for clinical studies to determine proper dosage. Relying on that data can accelerate clinical development by allowing drugmakers to transition more quickly into efficacy studies, the agency said.

The agency tells drugmakers to have the appropriate microbiological data before conducting such analyses. As an example, the agency suggests time-skill studies that will determine the relationship between concentrations and antimicrobial activities.