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RegisterYes, but why? [Regulatives / Guidelines]
Dear Helmut,
The product has already passed with reference replicate design as per USFDA guidelines. The decision to conduct pivotal as reference replicate design was based on the pilot study data.
The same product now needs to be marketed in Canada and therefore partial replicate design is the only choice as it does not meet BE with a 2-way crossover design.
Is there an alternate, by any chance has Health Canada approved any BE study with partial replicate design that you might have come across..
Regards
Chirag
The product has already passed with reference replicate design as per USFDA guidelines. The decision to conduct pivotal as reference replicate design was based on the pilot study data.
The same product now needs to be marketed in Canada and therefore partial replicate design is the only choice as it does not meet BE with a 2-way crossover design.
Is there an alternate, by any chance has Health Canada approved any BE study with partial replicate design that you might have come across..
Regards
Chirag
Complete thread:
- Reference replicate design for Canadian submission cakhatri 2013-04-22 11:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Yes, but why? Helmut 2013-04-22 12:53
- Yes, but why?cakhatri 2013-05-17 11:37
- Don’t use a partial replicate design! Helmut 2013-05-17 14:05
- Yes, but why?cakhatri 2013-05-17 11:37
- Yes, but why? Helmut 2013-04-22 12:53
Ing. Helmut Schütz