chandramohan
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2006-05-25 09:33
(7341 d 19:09 ago)

Posting: # 135
Views: 11,235
 

 quetiapine bioequivalance studies [Design Issues]

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Usually single dose Quetiapine Bioequivalence studies are done in normal healthy subjects, but multiple dose bioequivalence studies are done in schizophrenic patients. Quetiapine is having less side effects when compared to clozapine then why BE studies of Quetiapine are conducting in patients?

with regards,
Chandramohan
 
Helmut
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2007-06-01 15:02
(6969 d 13:39 ago)

@ chandramohan
Posting: # 770
Views: 7,199
 

 quetiapine bioequivalance studies

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Dear Chandramohan,

see FDA's Draft Guideline.
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velupharm
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2007-06-04 17:07
(6966 d 11:35 ago)

@ Helmut
Posting: # 778
Views: 6,788
 

 quetiapine bioequivalance studies

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Dear HS
can we follow the same strategy as suggested by USFDA, for submission with EU agencies?
 
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