chandramohan ● 2006-05-04 07:39 (6786 d 11:31 ago) Posting: # 103 Views: 9,743 |
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is it necessary to do drugs of abuse test at the beginning of each study period? |
Helmut ★★★ Vienna, Austria, 2006-05-04 16:28 (6786 d 02:42 ago) @ chandramohan Posting: # 104 Views: 7,850 |
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Dear chandramohan, this a tricky question! On one hand virtually all studies I have seen in the last ten years included a test for drugs of abuse at screenening and prior to administration in every treatment period (actually the evening of hospitalization). On the other hand all sponsors - and regulators as well - were happy just with the written acknowledgment that volunteers must not take any medicinal product without permission from the investigator for a certain period of time prior to the study and during the study. So we trust volunteers (in the case of additional medications), but we distrust them in the case of drugs of abuse. Clearly this is not a scientific rationale, but pragmatically I would recommend the drug tests — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
mitgandhi ● 2006-06-15 12:34 (6744 d 06:36 ago) @ Helmut Posting: # 148 Views: 7,707 |
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Dear Chandramohan & HS As far,no regulatory authority is stating about this, it is open. Further adding to your query, for which drugs subject should be screened? Regards Mitesh |
Helmut ★★★ Vienna, Austria, 2006-06-16 16:34 (6743 d 02:36 ago) @ mitgandhi Posting: # 154 Views: 7,791 |
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Dear Mitesh! ❝ [...] for which drugs subject should be screened? Depending on your expectations on the abuse practice in the local subject recruitment area... I would recommend benzodiazepines, amphetamine/methamphetamine, cocaine, opiates (+optional methadone), and cannabis. I would also consider screening for barbiturates obsolete. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
chintan98 ● 2006-07-11 09:38 (6718 d 09:32 ago) @ Helmut Posting: # 161 Views: 7,674 |
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As far as my experience says Drug abuse test should be done at the beginning of each study period. Because we have found Number of volunteers positive in this test at the beginning of Period II/III/IV. So it is advisable to do just at the beginning of each study period and it is really very easy and convenient to perform by medical nurse with the help of InstantView (KIT) Regards, Chintan Mehta |