FDA RSABE is ISC [🇷 for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 13:11 (1819 d 14:53 ago) – Posting: # 21709
Views: 31,161

Hi Detlew,

❝ Why not use the ISC estimate of T-R in the ABE decision in case of swR < 0.029356 (CVwR < 30%)?

❝ Politics? Nostalgia (Since years recommended the Proc MIXED code)?


The guidance “Statistical Approaches to Establishing Bioequivalence” of January 2001 (where the same SAS code is given in APPENDIX E) is still in force. Hence, it is only consistent to give it in the progesterone guidance.

❝ I would opt for the full ISC approach because it may be unambiguously implemented in SAS, R, Phoenix and so on for every replicate design, full or partial :cool:.


Cannot agree more. All problems would vanish.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,688 registered users;
67 visitors (0 registered, 67 guests [including 17 identified bots]).
Forum time: 04:05 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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