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RegisterHistory Lesson: FDA BA/BE guidance [Regulatives / Guidelines]
Sorry everyone,
I wanted to edit my question but I couldn't...
Does anyone have access to the old FDA BA/BE guidance that was issued about 199x? It was the guidance which required a SD fast study, a MD fast study and a 3-way food effect study? The food effect study BE critera was based on point estimates of Cmax and AUC to be within 80-125%?
Question... Was the guidance applicable to both immediate and extended release products?
Thanks
john
I wanted to edit my question but I couldn't...
Does anyone have access to the old FDA BA/BE guidance that was issued about 199x? It was the guidance which required a SD fast study, a MD fast study and a 3-way food effect study? The food effect study BE critera was based on point estimates of Cmax and AUC to be within 80-125%?
Question... Was the guidance applicable to both immediate and extended release products?
Thanks
john
Complete thread:
- History Lesson: FDA BA/BE guidance jag009 2012-04-18 17:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- History Lesson: FDA BA/BE guidancejag009 2012-04-19 19:39
- History Lesson: FDA BA/BE guidance drgunasakaran1 2012-05-01 13:23
- History Lesson: FDA BA/BE guidancejag009 2012-04-19 19:39
Ing. Helmut Schütz