data than can be obtained from clinical trials. 595-607 Recognizing all the To the extent the limitations noted above data are available, about body site provide a table of penetration, there are tissue penetration times when a clinician may by body site in the need to consider use of a SmPC. Sites without new agent for a patient indications can be with an infection at an as listed separately. yet unstudied body site. In The caveats on use such cases, having even a of such data should sense of low, medium or be noted. high penetration relative to plasma can be invaluable.
data than can be obtained from clinical trials. 595-607 Recognizing all the limitations noted above about body site penetration, there are times when a clinician may need to consider use of a new agent for a patient with an infection at an as yet unstudied body site. In such cases, having even a sense of low, medium or high penetration relative to plasma can be invaluable. To the extent the data are available, provide a table of tissue penetration by body site in the SmPC. Sites without indications can be listed separately. The caveats on use of such data should be noted.
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx