biowaiver for higher strength [Regulatives / Guidelines]
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.
- biowaiver for higher strength jag009 2022-01-24 07:48 [Regulatives / Guidelines]
- biowaiver for higher strengthdshah 2022-01-24 11:01
- Linearity Ohlbe 2022-01-24 12:16
- Linearity jag009 2022-01-24 15:06
- biowaiver for higher strength wienui 2022-02-01 09:12