be designed to address the potential for PPV to affect PK? How does one determine if PPV will affect the PK of a test agent based on its physicochemical properties? 407-408 While relevant for renally Revise to say “For cleared drugs, no allowance renally cleared made for drugs not drugs, including a impacted by renal function distribution for creatinine clearance that is usually found in the target population should be considered.”
be designed to address the potential for PPV to affect PK? How does one determine if PPV will affect the PK of a test agent based on its physicochemical properties? 407-408 While relevant for renally cleared drugs, no allowance made for drugs not impacted by renal function Revise to say “For renally cleared drugs, including a distribution for creatinine clearance that is usually found in the target population should be considered.”
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx