EMA: Waiving MD study [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-09-09 17:43 (381 d 14:12 ago) – Posting: # 21913
Views: 2,387

Hi Helmut,

» at the end an [image] script to play with.
»
» For any elimination half life of > 7 hours and an intended dosing interval of 24 hours it will be impossible to get the MD study waived. Red are formulations with flip-flop PK (kakel).

Could you please kindly add more explanation.

Cheers,
Osama

Complete thread:

Activity
 Admin contact
21,700 posts in 4,538 threads, 1,542 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Sunday 07:56 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