Pilot or pivotal ? [General Sta­tis­tics]

posted by jag009  – NJ, 2018-06-29 22:53 (1672 d 08:23 ago) – Posting: # 19000
Views: 11,372

Hi Olhbe

❝ Isn't the common practice to first test T1 and T2 vs. R in a pilot study (and I will not get into a debate on whether alpha correction would be needed), select one of the two test formulations, and then test it in a pivotal study in the usual way ? How often do you see both test formulations directly tested in a pivotal study ?


❝ OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?


Damn. We did pivotals 4-way crossover 3T vs R before! :surprised: R&D said no time and material was cheap! :confused: I said "Ooooookay..."
John

Complete thread:

UA Flag
Activity
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
14 visitors (0 registered, 14 guests [including 7 identified bots]).
Forum time: 06:16 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

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