Linearity [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-01-24 15:06 (123 d 02:17 ago) – Posting: # 22752
Views: 888

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.


Complete thread:

UA Flag
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 9 (0 registered, 9 guests [including 2 identified bots]).
Forum time: Friday 18:24 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz