FDA: new guidances expected in 2013 [BE/BA News]

posted by jag009  – NJ, 2013-02-13 16:44 (4876 d 01:41 ago) – Posting: # 10015
Views: 6,715

Hi Helmut,

❝ Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications. General Consideration


Do I smell them bringing back a 3-way food effect study (Test Fed, Ref Fed, Test Fast)?

John

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