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RegisterFDA: Biowaiver for other strengths [Regulatives / Guidelines]
Hi everyone,
For a generic product, can a biowaiver be filed for lower strengths AND upper strengths? If I have a generic product and the RLD is not the highest strength, can a biowaiver be filed for the highest strength? That is to do BE studies on the lower strength and claim biowaiver on higher strenghts since the strengths are dosage form proportional and similar in-vitro. Is this allowed due to safety reasons or simply because the RLD at highest strength is not available?
Thanks
John
For a generic product, can a biowaiver be filed for lower strengths AND upper strengths? If I have a generic product and the RLD is not the highest strength, can a biowaiver be filed for the highest strength? That is to do BE studies on the lower strength and claim biowaiver on higher strenghts since the strengths are dosage form proportional and similar in-vitro. Is this allowed due to safety reasons or simply because the RLD at highest strength is not available?
Thanks
John
Complete thread:
- FDA: Biowaiver for other strengthsjag009 2012-04-17 19:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: Biowaiver for other strengths Dr_Dan 2012-04-19 16:32
Ing. Helmut Schütz