biowaiver for higher strength [Regulatives / Guidelines]
❝ Based on the above, can I file a biowaiver for the higher strength test product so I don't have to run a PK BE study?
Are both strengths (low & high) follow the following EMA 5% & exceients rule?
Amount of API must be < 5% of tablet core weight, and
Amounts of excipients are same per strength, or
Only the amount of a filler is changed to account for changes in API weight.
- biowaiver for higher strength jag009 2022-01-24 07:48 [Regulatives / Guidelines]
- biowaiver for higher strength dshah 2022-01-24 11:01
- Linearity Ohlbe 2022-01-24 12:16
- Linearity jag009 2022-01-24 15:06
- biowaiver for higher strengthwienui 2022-02-01 09:12