549-551 There are a couple of Amend text as show sections which highlight by underlines: A that the PK/PD of the BLI index that needs to be defined for expresses the each BL. We suggest relationship consolidating some of this between drug recommendation into one exposures and place, and rather than antibacterial effects using a specific drug in preclinical models example to make the point, should be describe the reasons. established for each BLI. The PK-PD index should be established using bacterial strains that have been characterized for type of and other relevant resistance mechanisms to the beta-lactam and/or inhibitor (e.g., permeability-based) to understand the impact of varying organisms and
549-551 There are a couple of sections which highlight that the PK/PD of the BLI needs to be defined for each BL. We suggest consolidating some of this recommendation into one place, and rather than using a specific drug example to make the point, describe the reasons. Amend text as show by underlines: A index that expresses the relationship between drug exposures and antibacterial effects in preclinical models should be established for each BLI. The PK-PD index should be established using bacterial strains that have been characterized for type of and other relevant resistance mechanisms to the beta-lactam and/or inhibitor (e.g., permeability-based) to understand the impact of varying organisms and
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx