Bioequivalence and Bioavailability Forum • Linearity

Linearity [Regulatives / Guidelines]

posted by jag009 – NJ, 2022-01-24 16:06 (821 d 08:20 ago) – Posting: # 22752
Views: 2,259

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

Complete thread:

biowaiver for higher strength jag009 2022-01-24 07:48 [Regulatives / Guidelines]
- biowaiver for higher strength dshah 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
- Linearity Ohlbe 2022-01-24 12:16
  - Linearityjag009 2022-01-24 15:06
- biowaiver for higher strength wienui 2022-02-01 09:12