Dose escalation and DMC [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-07 12:18 (871 d 17:29 ago) – Posting: # 21064
Views: 2,352

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 🖖 [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,110 posts in 4,630 threads, 1,567 registered users;
online 3 (0 registered, 3 guests [including 1 identified bots]).
Forum time: Saturday 06:47 CEST (Europe/Vienna)

We can teach from our experience,
but we cannot teach experience.    Sasha Azevedo

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