marinela.chirila
●    

2007-05-15 14:57
(6984 d 18:20 ago)

Posting: # 728
Views: 6,589
 

 oxcarbazepine [Design Issues]

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hello,

Could you please tell me how many be studies are needed in the case of oxcarbazepine? 150mg, 300mg and 600mg tablets are developed.

thank you.

best regards,
Marinela
 
drcampos
★    

Brazil,
2007-05-16 21:27
(6983 d 11:50 ago)

@ marinela.chirila
Posting: # 729
Views: 5,283
 

 oxcarbazepine

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Dear Mirela,

It is generally required the BE study with the highest dosage (600mg) and dissolution profile for the others (150 and 300mg versus 600mg).

Daniel
 
marinela.chirila
●    

2007-05-18 12:01
(6981 d 21:16 ago)

@ drcampos
Posting: # 733
Views: 5,573
 

 oxcarbazepine

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Dear Daniel,

Thank you for your replay. I know that the highest strength is generally needed, if there is dose proportionality and the product has linear pharmacokinetics.
In the literature is reported that oxcarbazepine has linear pharmacokinetics over the dosage range of 300mg to 2400mg. 150mg is not included and I do not know if we have to do a study on this strength too.

Best regards,
Marinela
 
M.Vasu
★    

India,
2007-05-26 10:27
(6973 d 22:50 ago)

@ marinela.chirila
Posting: # 744
Views: 5,280
 

 oxcarbazepine

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In two situations i was observed oxcarbazepine study conducted study state conditions.

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Edit: Full quote removed. Please see this post! [HS]
 
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