3+3 Design [Design Issues]

posted by Pharma_88 – India, 2020-01-07 08:09 (867 d 01:55 ago) – Posting: # 21062
Views: 3,114

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:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 77 (2 registered, 75 guests [including 68 identified bots]).
Forum time: Monday 11:04 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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