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RegisterLinearity [Regulatives / Guidelines]
Hi Ohlbe,
» Does your drug show linear PK ? If not: does it show more-than-proportional increase (then the highest strength would be more sensitive to show differences in BA) or less-than-proportional increase (lowest strength would be more sensitive, giving you good arguments) ?
Yes its linear PK. I read the FDA guidance about Guidance, for NDA it seeems "possible" as long as one can provide safety and efficacy data.
John
» Does your drug show linear PK ? If not: does it show more-than-proportional increase (then the highest strength would be more sensitive to show differences in BA) or less-than-proportional increase (lowest strength would be more sensitive, giving you good arguments) ?
Yes its linear PK. I read the FDA guidance about Guidance, for NDA it seeems "possible" as long as one can provide safety and efficacy data.
John
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 strength dshah 2022-01-24 11:01
- biowaiver for higher strength jag009 2022-01-24 15:09
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- Linearity Ohlbe 2022-01-24 12:16
- Linearityjag009 2022-01-24 15:06
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- biowaiver for higher strength dshah 2022-01-24 11:01
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