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RegisterDose for BE Studies [Design Issues]
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
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
Complete thread:
- Dose for BE Studies hiren379 2012-10-06 06:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dose for BE Studiesjag009 2012-10-08 18:12
- Dose for BE Studies cakhatri 2012-10-09 07:31
Ing. Helmut Schütz