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RegisterMR ANDA [Regulatives / Guidelines]
Dear Eswar,
Please do not do fasting study for any strength of venlafaxine. Kindly see the literature on administration of venlafaxine. It should be given only with food. We have extensive experience on venlafaxine biostudies. The major adverse event if it is administered in empty stomach is heavy nausea and eventually vomiting. This is not an easy molecule.
Regards
Dr. Shiv
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Edit: Full quote removed. [HS]
Please do not do fasting study for any strength of venlafaxine. Kindly see the literature on administration of venlafaxine. It should be given only with food. We have extensive experience on venlafaxine biostudies. The major adverse event if it is administered in empty stomach is heavy nausea and eventually vomiting. This is not an easy molecule.
Regards
Dr. Shiv
--
Edit: Full quote removed. [HS]
Complete thread:
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- MR ANDA Jaime_R 2007-01-09 17:49
- MR ANDAdrshiv 2007-02-28 18:26
- venlafaxine study velupharm 2007-03-01 17:00
- venlafaxine study Helmut 2007-06-01 12:45
Ing. Helmut Schütz