Linearity [Regulatives / Guidelines]

posted by Ohlbe – France, 2022-01-24 13:16 (1014 d 17:01 ago) – Posting: # 22751
Views: 3,180

Hi 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) ?

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,280 posts in 4,889 threads, 1,655 registered users;
58 visitors (0 registered, 58 guests [including 13 identified bots]).
Forum time: 06:17 CET (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5