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

posted by dshah  – India/United Kingdom, 2022-06-23 14:52 (459 d 19:52 ago) – Posting: # 23073
Views: 906

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.
Divyen Shah

Complete thread:

UA Flag
 Admin contact
22,759 posts in 4,775 threads, 1,628 registered users;
14 visitors (0 registered, 14 guests [including 5 identified bots]).
Forum time: 10:45 CEST (Europe/Vienna)

Whenever a theory appears to you as the only possible one,
take this as a sign that you have neither understood the theory
nor the problem which it was intended to solve.    Karl R. Popper

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