417-418 Sponsor should consider Modify text to and incorporating these factors suggest instead that into the core justification of the presentation the PDT(s) used in should on the simulations, instead of PTA for the relevant increasing the number of PDT for the given PTA analyses. The text indication and implies potential for population. generating a large number of tables/figures.
417-418 and Sponsor should consider incorporating these factors into the core justification of the PDT(s) used in simulations, instead of increasing the number of PTA analyses. The text implies potential for generating a large number of tables/figures. Modify text to suggest instead that the presentation should on the PTA for the relevant PDT for the given indication and population.
efpia_comments_draft_guideline_ema_pk-pd_antibacterial_final.docx