members of an existing clinical and drug class nonclinical data for existing approved antimicrobial agents as for “benchmarks” determining the PDTs of new agents. In these cases, the extent of bacterial killing and PDTs in nonclinical models with humanized exposures of an existing approved agent may provide a target “benchmark” for the new agent from the same class. The sponsor should provide justification of PDTs selected for use in analyses of PTA by considering clinical endpoints, disease severity, burden level of the pathogen, and drug
members of an existing drug class clinical and nonclinical data for existing approved antimicrobial agents as “benchmarks” for determining the PDTs of new agents. In these cases, the extent of bacterial killing and PDTs in nonclinical models with humanized exposures of an existing approved agent may provide a “benchmark” target for the new agent from the same class. The sponsor should provide justification of PDTs selected for use in analyses of PTA by considering clinical endpoints, disease severity, burden level of the pathogen, and drug
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx