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Irukulla Shravan Kumar ★ India, 2014-04-24 09:31 (4445 d 07:47 ago) Posting: # 12880 Views: 3,704 |
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Dear sir, why do we instruct the volunteer/subject for not consuming the alochol, xanthine and grapefruit juice from a spcified period of time (like from 24 hrs/48 hrs from each period)?? what is the impact on these studies. kindly address me. Regards, I.Shravan |
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Dr_Dan ★★ Germany, 2014-04-24 11:30 (4445 d 05:49 ago) @ Irukulla Shravan Kumar Posting: # 12882 Views: 3,020 |
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Dear I.Shravan A clinical trial should be standardized as much as possible. Volunteer/subject are advised not to consume alochol, xanthine and grapefruit juice in order to avoid possible pharmacokinetic and/or pharmacodynamic interaction with the investigational drug and by this to ensure safety of the volunteers/subjects. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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krish ☆ India, 2014-05-03 15:30 (4436 d 01:49 ago) @ Dr_Dan Posting: # 12911 Views: 2,909 |
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Dear Dr_Dan Its good to standardise a bioequivalence as much as possible. But how to confirm that the subject has not taken alcohol/ grape fruit/ any other objectionable items 24 hour/ 48 hour before drug administration. because usually it is just confirmed by asking the subject/ volunteer Orally. If he/she says that they have not consumed, inspite of taking them. Regards, KRISH  |
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SDavis ★★  UK, 2014-05-20 16:23 (4419 d 00:56 ago) @ krish Posting: # 12977 Views: 2,702 |
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❝ But how to confirm that the subject has not taken alcohol/ grape fruit/ any other objectionable items 24 hour/ 48 hour before drug administration. In my experience most CROs run a standard drugs screen at check-in (in addition to screening) so you can confirm before/at dosing that the subjects have complied with the exclusion criteria by confirming absence of alcohol, caffeine and their metabolites as well as other drugs of abuse e.g. cannabinoids, opiates (avoid poppy seeds!). Simon. — Simon Senior Scientific Trainer, Certara™ [link=https://www.youtube.com/watch?v=xX-yCO5Rzag[/link] https://www.certarauniversity.com/dashboard https://support.certara.com/forums/ |
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