Dose escalation and DMC [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-07 12:18 (619 d 11:46 ago) – Posting: # 21064
Views: 2,155

Hi Pharma_88,

I agree with what Ohlbe wrote.

Note that the decision on whether or not to proceed to the next cohort must not be done at the clincal site but by an external Data Monitoring Committee (DMC). See also the EMA’s Guideline.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,689 posts in 4,534 threads, 1,541 registered users;
online 12 (0 registered, 12 guests [including 1 identified bots]).
Forum time: Saturday 01:04 CEST (Europe/Vienna)

Old beliefs die hard
even when demonstrably false.    E. O. Wilson

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