Mugdha
●    

2008-02-04 18:22
(6717 d 01:02 ago)

Posting: # 1578
Views: 6,251
 

 Quetiapine Fumarate SR Tablets BE [Design Issues]

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Hi....

Can anybody explain how BE study can be planned for Quetiapine Fumarate SR Tablet? what is expected from regulatory agency like US FDA? do we need to do study in normal subjects or in schiznophrenic patients? can anybody proide inputs?
 
Helmut
★★★
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Vienna, Austria,
2008-02-04 19:11
(6717 d 00:13 ago)

@ Mugdha
Posting: # 1580
Views: 4,188
 

 Quetiapine Fumarate SR Tablets BE

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Dear Mugdha!

❝ what is expected from regulatory agency like US FDA?


See FDA's draft.
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hsan
●    

2008-02-05 12:15
(6716 d 07:10 ago)

@ Mugdha
Posting: # 1584
Views: 4,120
 

 Quetiapine Fumarate SR Tablets BE

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We have to do on schizophrenic patients. We are doing one study already. It is not simple protocol.

--
Edit: Full quote removed. Please see this post, and the Policy as well! [HS]
 
Rajdeep
★    

New Delhi, India,
2008-02-07 09:01
(6714 d 10:23 ago)

@ hsan
Posting: # 1594
Views: 4,067
 

 Quetiapine Fumarate SR Tablets BE

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Dear All

Better go for a safety evaluation study first. Subject # can be taken as 16 in this case.
—
Best regards
Rajdeep Mukherjee
Protocol Developer
 
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