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RegisterFed study for Sublingual Tablets [Design Issues]
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.
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
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
Complete thread:
- Fed study for Sublingual Tablets Compliance 2012-08-29 07:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fed study for Sublingual Tabletsdrgunasakaran1 2012-08-29 11:36
Ing. Helmut Schütz