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RegisterHistory Lesson: FDA BA/BE guidance [Regulatives / Guidelines]
Hi everyone,
Can someone give me a history lesson on the differences between the old and new FDA requirement on BE studies with respect to the fed study?
Correct me if I am wrong... The previous requirement was a 3-way (Test Fast, Test Fed, Reference Fed) with Cmax based on T/R ratios AUCs based on 90% CI?
Thanks
John
Can someone give me a history lesson on the differences between the old and new FDA requirement on BE studies with respect to the fed study?
Correct me if I am wrong... The previous requirement was a 3-way (Test Fast, Test Fed, Reference Fed) with Cmax based on T/R ratios AUCs based on 90% CI?
Thanks
John
Complete thread:
- History Lesson: FDA BA/BE guidancejag009 2012-04-18 17:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- History Lesson: FDA BA/BE guidance jag009 2012-04-19 19:39
- History Lesson: FDA BA/BE guidance drgunasakaran1 2012-05-01 13:23
- History Lesson: FDA BA/BE guidance jag009 2012-04-19 19:39
Ing. Helmut Schütz