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RegisterWhat if the References listed drug changed strength? [Regulatives / Guidelines]
Hi all,
If an agency (FDA/EMA or etc) updates the BE guidance to switch the Reference Listed Drug (RLD) to a higher strength, is it possible to claim biowaiver for the higher strength based on proportionality if one already has an approval on the drug product based on BE studies conducted at lower strength RLD -> The previous BE guidance involved a lower strength RLD.
In short, what I am asking is can biowaiver be claimed for higher strength?
Thanks
John
If an agency (FDA/EMA or etc) updates the BE guidance to switch the Reference Listed Drug (RLD) to a higher strength, is it possible to claim biowaiver for the higher strength based on proportionality if one already has an approval on the drug product based on BE studies conducted at lower strength RLD -> The previous BE guidance involved a lower strength RLD.
In short, what I am asking is can biowaiver be claimed for higher strength?
Thanks
John
Complete thread:
- What if the References listed drug changed strength?jag009 2016-05-20 17:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- What if the References listed drug changed strength? Mauricio Sampaio 2016-05-20 18:56
- What if the References listed drug changed strength? jag009 2016-05-20 21:48
- What if the References listed drug changed strength? nobody 2016-05-20 19:04
- What if the References listed drug changed strength? Mauricio Sampaio 2016-05-20 18:56
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