Regulatory acceptance pre-mature discontinuation of study [Study Per­for­mance]

posted by dshah  – India/United Kingdom, 2022-06-23 14:52 (165 d 01:29 ago) – Posting: # 23073
Views: 497

Dear Vaibhav!
From your initial post, I assume the study is required to be performed in diseased condition and anticipate a steady state condition instead of single dose. Further, standardization of patient might be required and thus higher number of dose compensation for patient might be required. Thus, the dropout consideration might be high. What is really surprising, if I am understanding correct than, the assumed T/R and ISCV.
We had faced slightly different condition for NTI drug where RLD got expired during COVID period, and drop out was high due to +ve subjects. For one parameter, the acceptance criteria was not met as per FDA, and the study was rejected.
Addition of new lot of RLD will greatly increase complexity of statistics, too.
Regards,
Divyen Shah

Complete thread:

UA Flag
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
14 visitors (0 registered, 14 guests [including 6 identified bots]).
Forum time: 15:22 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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