joyjac
★    

Philippines,
2010-02-10 03:17
(5984 d 12:59 ago)

Posting: # 4742
Views: 4,411
 

 Clozapine [Design Issues]

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Dear colleagues,

Has anyone done a BE on Clozapine Tablet? Would appreciate any inputs on this matter, particularly, design of study, type of subjects, dose administration. Thanks.

Edit: Category changed. [Helmut]
 
Helmut
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Vienna, Austria,
2010-02-11 16:26
(5982 d 23:50 ago)

@ joyjac
Posting: # 4751
Views: 3,545
 

 Clozapine

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Dear Joy,

only as an entry point:
W Tassaneeyakul et al.
Steady-state bioequivalence study of clozapine tablet in schizophrenic patients
J Pharm Pharmaceut Sci 8(1), 47-53 (2005)
online resource
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raghu
★    

India,
2010-02-14 08:53
(5980 d 07:23 ago)

@ joyjac
Posting: # 4761
Views: 3,340
 

 Clozapine

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Dear Joy,

USFDA had issued specific guidance on clozapine tablets.

You can follow the guidance, if you are planning to submit the biostudy to USFDA. I hope it may helps you.

Regards
Raghavender.Chenna
 
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