3+3 Design [Design Issues]

posted by Pharma_88 – India, 2020-01-07 08:09 (747 d 21:53 ago) – Posting: # 21062
Views: 2,937

Hello All,

This is regarding 3+3 design for Phase-I trial. I have searched online and found some articles on design. My Question is that once the group/cohort is completed with 3 patients, whether same patients will be enrolled in next cohort or new patient will be enrolled? Further, in next cohort suppose 1 patient is withdarwn or have some AE then its compulsory to add 3 more patients to inline with multiplication of 3?

Thanks,
Pharma_88

Complete thread:

Activity
 Admin contact
21,844 posts in 4,571 threads, 1,555 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Monday 06:03 CET (Europe/Vienna)

Do, or do not.
There is no ‘try’.    Yoda

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