Estimated knowledge [RSABE / ABEL]

posted by sdu – 2010-01-26 22:21 (5588 d 18:38 ago) – Posting: # 4649
Views: 15,025

Thank you for the nice summary of Toutfalusi et al.'s paper
I also read the Hyslop et al article on "A small sample confidence interval approach to assess individual bioequivalence" (Statistic in Med 2000, 19, pp2885-2897).
I have few questions
  1. How do you calculate the sint? Based on the Hyslop's paper the subject by formulation interaction is calculated using sigD, sigwt, and sigwr. Is this the way to calculate based on Hyslop et al. paper?
  2. If above statement is correct do we assume sigwt is equal to sigwr, as stated by Ekbohm and Melander et al. in "The subject-by-formulation interaction as a criterion for interchangeability of drugs". (Biometrics 1989; 45:1249-1254).
  3. It was my understanding that Reference scaled Average BE is the special case of the IBE where we assume sigD is negligible and the sigwt is equal or smaller than the sigwr. Is this correct?
In advance thank you for your input on the above questions
Kindly
sdu

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
149 visitors (0 registered, 149 guests [including 12 identified bots]).
Forum time: 17:59 CEST (Europe/Vienna)

A statistical analysis, properly conducted, is a delicate dissection of
uncertainties, a surgery of suppositions.    Micheal J. Moroney

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