438-449 Appropriate that Suggest risk:benefit be considered. emphasizing value No mention of how to of PTA as tool for handle combinations (e.g. relative comparison BL/BLIs) and if joint PTA with known preferred method versus members of the other integrated approach class, other internal through approaches such as controls, or between a dynamic MIC or a organs, indications, pharmacometric-based pathogens or PDTs, mechanistic model. instead of focusing on a specific numerical PTA cut off (i.e., specific targets such as 90% PTA should be given as examples rather than hard targets).
438-449 Appropriate that risk:benefit be considered. No mention of how to handle combinations (e.g. BL/BLIs) and if joint PTA preferred method versus other integrated approach through approaches such as a dynamic MIC or a pharmacometric-based mechanistic model. Suggest emphasizing value of PTA as tool for relative comparison with known members of the class, other internal controls, or between organs, indications, pathogens or PDTs, instead of focusing on a specific numerical PTA cut off (i.e., specific targets such as 90% PTA should be given as examples rather than hard targets).
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx