Pilot or pivotal ? [General Sta­tis­tics]

posted by jag009  – NJ, 2018-06-29 18:53 (1085 d 08:24 ago) – Posting: # 19000
Views: 9,805

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..."

Complete thread:

 Admin contact
21,529 posts in 4,499 threads, 1,523 registered users;
online 7 (0 registered, 7 guests [including 2 identified bots]).
Forum time: Saturday 03:17 UTC (Europe/Vienna)

Anyone who has never made a mistake
has never tried anything new.    Albert Einstein

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