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RegisterErgocalciferol Bioequivalence [Regulatives / Guidelines]
I am aware of the draft guidance. However it's just a nonbinding draft. Ergocalciferol is rated "AA" therapeutic equivalent by FDA, which means it is technically eligible for a biowaiver. Moreover, it's also a BC Class III which means it is also eligible on that basis.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- Ergocalciferol Bioequivalence hnasri 2014-04-30 20:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ergocalciferol Bioequivalence student_pharmacologist 2014-05-01 12:47
- Ergocalciferol Bioequivalencehnasri 2014-05-01 16:59
- Ergocalciferol Bioequivalence Ohlbe 2014-05-01 18:13
- Ergocalciferol Bioequivalencehnasri 2014-05-01 16:59
- Ergocalciferol Bioequivalence student_pharmacologist 2014-05-01 12:47
Ing. Helmut Schütz