520 For BL-BLI the Somewhere in a concentration of BLI used in subsection of 4.6 susceptibility testing often (at the end of the gets linked with the paragraph concentration(s) used to beginning on line define the PK/PD 529 would make relationship. A there is sense), add this currently no mention of text: In addition, susceptibility testing in the the fixed document, we feel it would concentration of BLI be helpful to add some used in in vitro clarity around the susceptibility testing differences. does not necessarily relate to target threshold concentrations from PK/PD experiments that describe the PDT.
520 For BL-BLI the concentration of BLI used in susceptibility testing often gets linked with the concentration(s) used to define the PK/PD relationship. A there is currently no mention of susceptibility testing in the document, we feel it would be helpful to add some clarity around the differences. Somewhere in a subsection of 4.6 (at the end of the paragraph beginning on line 529 would make sense), add this text: In addition, the fixed concentration of BLI used in in vitro susceptibility testing does not necessarily relate to target threshold concentrations from PK/PD experiments that describe the PDT.
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx