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RegisterANVISA – likely no scaling [Regulatives / Guidelines]
Dear Kotu and Helmut
Recently we submitted our protocol for a Replicate study designs (2 treatments, 4 periods replicate) of one Highly variable drug product (ISCV~45%) and asked for their opinion on the widening criteria.
And they royally rejected the idea of widening the Cmax quoting that they have a successful BE results with 44 volunteers in a 2 way crossover study thus we need to fulfill the same criteria
Recently we submitted our protocol for a Replicate study designs (2 treatments, 4 periods replicate) of one Highly variable drug product (ISCV~45%) and asked for their opinion on the widening criteria.
And they royally rejected the idea of widening the Cmax quoting that they have a successful BE results with 44 volunteers in a 2 way crossover study thus we need to fulfill the same criteria
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Replicate study design for Brazil submission balakotu 2012-11-14 09:49 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
- ANVISA – likely no scalingluvblooms 2012-11-16 05:27
- ANVISA: strange Helmut 2012-11-16 14:14
- ANVISA – likely no scalingluvblooms 2012-11-16 05:27
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
Ing. Helmut Schütz