473-474 We agree that there are We agree with and well-delineated limitations support retention of for deriving E-R the language noting relationships in some the limitations of settings. analyses and support reliance on Although such analyses nonclinical targets in should be attempted by this setting. Sponsors, it may not be possible to derive clinical PDTs in all settings, supporting reliance on nonclinical targets. 486-493 This section is unclear as it Please expand this relates to E-R analyses. section to clarify intentions or delete the section
473-474 We agree that there are well-delineated limitations for deriving E-R relationships in some settings. Although such analyses should be attempted by Sponsors, it may not be possible to derive clinical PDTs in all settings, supporting reliance on nonclinical targets. We agree with and support retention of the language noting the limitations of analyses and support reliance on nonclinical targets in this setting. 486-493 This section is unclear as it relates to E-R analyses. Please expand this section to clarify intentions or delete the section
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx