MGR ★ India, 2008-02-21 06:13 (5880 d 16:25 ago) (edited by MGR on 2008-02-21 08:10) Posting: # 1623 Views: 5,445 |
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Dear All, 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? Thank you. — Regards, MGR |
Helmut ★★★ Vienna, Austria, 2008-03-10 19:58 (5862 d 02:40 ago) @ MGR Posting: # 1673 Views: 4,253 |
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Dear MGR! ❝ 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? Very doubtful... Edit: Link corrected to latest archived copy. [Helmut] — 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 |