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Registerbiowaiver for higher strength [Regulatives / Guidelines]
Hi John!
Interesting question but when we revisit guidelines, the biowaiver recommendation is mostly for lower strength formulation only. I believe that the criteria of not using higher strength due to safety/AE if justifiable, then may be used to support waiver using lower strength.
Regards,
Dshah
Interesting question but when we revisit guidelines, the biowaiver recommendation is mostly for lower strength formulation only. I believe that the criteria of not using higher strength due to safety/AE if justifiable, then may be used to support waiver using lower strength.
Regards,
Dshah
Complete thread:
- biowaiver for higher strength jag009 2022-01-24 07:48 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- biowaiver for higher strengthdshah 2022-01-24 11:01
- biowaiver for higher strength jag009 2022-01-24 15:09
- biowaiver for higher strength dshah 2022-01-24 20:18
- biowaiver for higher strength dshah 2022-02-03 19:07
- biowaiver for higher strength jag009 2022-01-24 15:09
- Linearity Ohlbe 2022-01-24 12:16
- Linearity jag009 2022-01-24 15:06
- biowaiver for higher strength wienui 2022-02-01 09:12
- biowaiver for higher strengthdshah 2022-01-24 11:01
Ing. Helmut Schütz