Bioequivalence and Bioavailability Forum • Brave New World (no pun!)

Helmut
★★★

Vienna, Austria,
2013-01-22 00:06
(4534 d 22:20 ago)

Posting: # 9895
Views: 5,431

Brave New World (no pun!) [Two-Stage / GS Designs]

Sequential Designs and Interim Analyses
in Bioequivalence: FDA’s
Experience

Barbara M. Davit, Ph.D., J.D.
Director, Division of Bioequivalence II
Office of Generic Drugs, CDER, FDA

Mini-Symposium on Adaptive Study Designs and Assessment
Approaches for Bioequivalence
AAPS Annual Meeting
Chicago, IL
October 13-18, 2012

[image]

[image]

P.S.: No slide about Method B. :-D

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

ElMaestro
★★★

Denmark,
2013-01-22 11:51
(4534 d 10:34 ago)

@ Helmut
Posting: # 9896
Views: 4,368

Brave New World (no pun!)

Post reply

Hi Helmut,

thanks for posting. I think this is a step in the right direction. To me meffud B and C are pretty similar in terms of the work needed to plan and conduct the study, and since the two meffuds have nearly equal performance I have little or no preference myself. I am just happy FDA is giving one of them the green light.

Now we just need some considerations over stoping criteria and higher target power than 80% :-D

and oooohh aaah parallel studies.

Have a great day.

—
Pass or fail!
ElMaestro