types on the PDT for the BLI. 552-554 The current Amend text as show recommendation is that in by underlines: In non-clinical infection establishing the models the BL/BLI should index, studies be administered to mimic should be included the anticipated mode(s) of in non-clinical clinical use. We agree, but infection models also note that there are wherein the BL/BLI studies used during should be development of the PK/PD administered to understanding which may mimic the not mimic the mode of anticipated mode(s) clinical use, but still have of clinical use…… utility and should not be discouraged. Thus we propose a slight modification to the text.
types on the PDT for the BLI. 552-554 The current recommendation is that in non-clinical infection models the BL/BLI should be administered to mimic the anticipated mode(s) of clinical use. We agree, but also note that there are studies used during development of the PK/PD understanding which may not mimic the mode of clinical use, but still have utility and should not be discouraged. Thus we propose a slight modification to the text. Amend text as show by underlines: In establishing the index, studies should be included in non-clinical infection models wherein the BL/BLI should be administered to mimic the anticipated mode(s) of clinical use……
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx