ER vs. IR [Design Issues]

posted by Dr_Dan  – 2019-12-19 09:01 (284 d 13:50 ago) – Posting: # 21004
Views: 1,609

Hi Helmut
your statement only holds true in your example with different strengths. If you have only one or the highest IR strength then my statement applies. The once daily (or 8 h) dosing of the ER formulation does not have to mimicry the performance of the multiple dosing of the IR formulation if you can show that there is a well-defined therapeutic window in terms of safety and efficacy and the rate of input is known not to influence the safety and efficacy profile or the risk for tolerance development.
KR
Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

Activity
 Admin contact
21,084 posts in 4,398 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Monday 23:51 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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