Pilot or pivotal ? [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2018-06-27 13:01 (816 d 09:21 ago) – Posting: # 18977
Views: 8,089

Hello Ohlbe

» 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 ?

That's right. I have never seen an evaluation of two tests in a single study in which the applicant hoped for approval of both.

» 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 ?

Yes absolutely. The majority of dossiers are being accepted without pilot trials. Whether to go for a pilot before a pivotal is dictated by many factors. First to file is a very significant one, but also involved is BCS class, budgets, previous failures ("You guys need to start showing some results!"), gut feeling and much more.
However I get slightly worried when you are suddenly allowing the term sense to enter this discussion. My empirical observation is that that term has absolutely no place in the planning of BE studies.:-D

I could be wrong, but...

Best regards,
ElMaestro

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

Activity
 Admin contact
21,068 posts in 4,392 threads, 1,465 registered users;
online 10 (0 registered, 10 guests [including 6 identified bots]).
Forum time: Sunday 22:23 CEST (Europe/Vienna)

Data is not information.
Information is not knowledge.
And knowledge is certainly not wisdom.    Clifford Stoll

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