MGR
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India,
2008-02-21 05:13
(edited by MGR on 2008-02-21 08:10)

Posting: # 1623
Views: 3,990
 

 Meta Analysis [Off Topic]

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
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Vienna, Austria,
2008-03-10 18:58

@ MGR
Posting: # 1673
Views: 3,146
 

 Meta Analysis

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
  • generally just underpowered to do so (pragmatic view),
  • not planned to do so (hardcore statistical view).
There are anecdotal reports that drugs got approval based on the results of a pilot study only (if properly planned, executed, and sized - whatever that means), but I would not bet on it.
The only references I know are http://www.fda.gov/cder/guidance/5356fnl.pdf FDA's BE-guidance (Section III.A.2., last sentence) and a personal conversation with a Swedish regulator I had in May 2006…
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
Bioequivalence studies: biometrical concepts of alternative designs and pooled analysis
Eur J Drug Metabol Pharmacokinet 24, 225-232 (1999)


Chapter 13 of Chow & Liu (2001) also deals with Meta-Analysis of average BE.

» Is it acceptable by the regulatory bodies?

Very doubtful... :no:


Edit: Link corrected to latest archived copy. [Helmut]

Cheers,
Helmut Schütz
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