Dose for BE Studies [Design Issues]

posted by jag009  – NJ, 2012-10-08 20:12 (5010 d 10:55 ago) – Posting: # 9340
Views: 2,435
(edited on 2012-10-08 20:40)

Hi Hiren,

No BE guidance on this drug at FDA website?
Usually BE studies are done at highest strength of the formulation unless there are safety issues (ie: BE for Wellbutrin XL is at 150 mg. 300 mg strength tablets are not studied due to safety issues).

John

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