(edited by MGR on 2008-02-21 08:10)
Posting: # 1623
Can anybody tell me about Meta Analysis method used in BA/BE Studies (For example: one passed pilot Be study and pivotal BE study, one failed pivotal BE study). If there is any sites or references regarding this kindly provide. Is it acceptable by the regulatory bodies?
Posting: # 1673
» Can anybody tell me about Meta Analysis method used in BA/BE Studies (For example: one passed pilot Be study and pivotal BE study, one failed pivotal BE study).
Please see this post for the proper terminology.
A pilot study is always exploratory in nature, i.e., it's purpose is to get estimates of CVintra and the point estimate, and to check the suitability of the dosage regimen, the sampling schedule, and the analytical method. If a pilot study gives a confidence interval within the accteptance range, that's nice, but no proof of BE because such a study is
The only references I know are
BTW, if you have a passed pilot and a pivotal BE, why did you perform yet another pivotal BE study?
Canada and Japan allow for add-on designs – but that's a different cup of tea…
» If there is any sites or references regarding this kindly provide.
A rather questionable reference is
E Zintzaras and P Bouka
Chapter 13 of Chow & Liu (2001) also deals with Meta-Analysis of average BE.
» Is it acceptable by the regulatory bodies?
Edit: Link corrected to latest archived copy. [Helmut]
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