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uday ● 2008-11-12 16:08 (6079 d 17:13 ago) Posting: # 2661 Views: 4,996 |
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Dear all, we are conducting a bioequivalence study wherein we need to dose 10 capsules at a time to the subject. can anyone please explain how to dose so many capsules with 240 mL of water. is the process mentioned in any of the guidelines? kindly help me out. |
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yousufmohiuddin ● 2008-11-16 15:46 (6075 d 17:35 ago) (edited on 2008-11-16 22:56) @ uday Posting: # 2677 Views: 3,767 |
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As of I am concerned there is no guidelines. But FDA do suggest to dose 10 tablets or 05 to 06 tablets for certain drugs. Then the question remains how? Isn't it? For me make it simple, just divide this 240mL of water into possibly 3 or 4 parts and then administer 3 or 4 tablets at a time synchronizing it with divided water parts, that may actually makes it more convenient. More importantly have test dosing with identical placebos to the test and reference, so that you guys have clear cut idea, what would be required. Tablet or capsule size is important, if it is small and hopefully it is, then it can be done. -- Edit: Full quote removed. Please see this post! [Ohlbe] |
Ing. Helmut Schütz