joyjac
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Philippines,
2006-10-10 03:15

Posting: # 297
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 BE Studies by innovators [Off Topic]

Would you know where innovator companies conduct their BE studies? I have come across several BE studies (in addition to BA) done by innovator companies submitted as part of the NDA application but there was no mention of the BE testing center. Do they do it in-house or avail of the facilities and services of a Clinical Research Organization? Thanks.
Helmut
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Vienna, Austria,
2006-10-10 11:29

@ joyjac
Posting: # 298
Views: 3,834
 

 BE Studies by innovators

Dear Joy!

» Would you know where innovator companies conduct their BE studies? I have come across several BE studies (in addition to BA) done by innovator companies submitted as part of the NDA application but there was no mention of the BE testing center. Do they do it in-house or avail of the facilities and services of a Clinical Research Organization?

Innovators have to perform BE studies if they are changing their formulations during product development (e.g., going from formulations used in the first clinical studies to formulation intended for marketing).
They do their studies both in-house and at external CROs.
As a general rule they show more trust in larger, well-established CROs - in small CROs they may be suspicious of some kind of 'information leaking' ;-)
As seen from a medium-sized CRO's (20 BE studies/year) perspective, I would estimate only ~5% of BE studies performed sponsored by innovators (although the percentage may be somewhat higher if you include food- and PK-interaction studies as well).

Cheers,
Helmut Schütz
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joyjac
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Philippines,
2006-10-11 10:24

@ Helmut
Posting: # 307
Views: 3,672
 

 BE Studies by generic companies

Many thanks! How about companies producing generic drug products doing their BE studies in-house - any comment on this?
Helmut
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Vienna, Austria,
2006-10-11 12:29

@ joyjac
Posting: # 308
Views: 3,788
 

 BE Studies by generic companies

Dear Joy!

» How about companies producing generic drug products doing their BE studies in-house - any comment on this?

As seen from my (biased European) perspective almost all generic companies (including some of the really big 'global players') perform their studies at external CROs.

Cheers,
Helmut Schütz
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