EMA: Waiving MD study [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-09-09 17:43 (375 d 02:09 ago) – Posting: # 21913
Views: 2,383

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
21,691 posts in 4,534 threads, 1,541 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 19:52 CEST (Europe/Vienna)

If you want to get people to believe
something really, really stupid,
just stick a number on it.    Charles Seife

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