Compliance
★    

India,
2012-08-29 09:55
(5051 d 16:07 ago)

Posting: # 9121
Views: 3,166
 

 Fed study for Sublingual Tablets [Design Issues]

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Dear All,

Kindly give me the clarity about "is the fed study is requires for the Sublingual Tablets or only fasting is OK? if no then why it is so? i have tried to get some literature but unable to get the desire clarity.

Regards,

Compliance
 
drgunasakaran1
★★  
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2012-08-29 13:36
(5051 d 12:25 ago)

@ Compliance
Posting: # 9122
Views: 2,647
 

 Fed study for Sublingual Tablets

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Dear Mr Compliance,

In some cases, Fed studies are required for Sublingual tablets. But, we can able to give appropriate answer only if you can able to provide us the molecule name of your sublingual tablets, whether it is IR/MR and for which country of submission.?

Please Refer FDA's Recommendation on Zolpidem sublingal Tablet, where FDA suggests to do both Fasting and Fed studies.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
 
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