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konkous ☆ Greece, 2011-03-01 22:08 (5599 d 03:47 ago) Posting: # 6678 Views: 3,157 |
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Dear forum members I wonder if there is a specific guideline regarding hospitalization and monitoring of study subjects during a BE study. For example, in a Fluconazole capsule BE study with the last sample received 96 hours after administration do the volunteers need to stay at the clinical site during the entire period? If not, is it necessary to somehow verify that the subject hasn't received any other medication or substance that could influence the pharmacokinetics? |
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manan ☆ Ahmedabad, 2011-03-03 08:24 (5597 d 17:31 ago) @ konkous Posting: # 6690 Views: 2,758 |
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Dear Konkous the subjects can be called on ambulatory visits for all the blood samples after their housing period. lets say the subjects can be housed for 24 or 48 hours post dose and the rest samples can be taken as ambulatory samples. You can carry out compliance assessment during this ambulatory samples to check whether the subjects has not consumed any unsual diet or have followed the restrictions to be observed during the trial so that the PK profile is not altered. |
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Helmut ★★★   Vienna, Austria, 2011-03-03 14:39 (5597 d 11:15 ago) @ manan Posting: # 6696 Views: 2,673 |
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Dear Manan! ❝ You can carry out compliance assessment during this ambulatory samples to check whether the subjects has not consumed any unsual diet or have followed the restrictions to be observed during the trial so that the PK profile is not altered. What do you mean by “compliance assessment”? Interrogating subjects? What answers do you expect? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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manan ☆ Ahmedabad, 2011-03-05 08:29 (5595 d 17:25 ago) @ Helmut Posting: # 6708 Views: 2,622 |
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Dear HS The subjects will give positive replies. But we can have in place some tests (like breath tests for alcohol and smoking tests) with which we can confirm that subjects have not violated any restrictions. I think having such tests in place can give accurate results. I am waiting for your suggestions as well. |
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Helmut ★★★ Vienna, Austria, 2011-03-05 13:38 (5595 d 12:17 ago) @ manan Posting: # 6709 Views: 2,637 |
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Dear Manan! ❝ [...] we can have in place some tests (like breath tests for alcohol and smoking tests) with which we can confirm that subjects have not violated any restrictions. ❝ ❝ I think having such tests in place can give accurate results. Yes, these test are reliable. But you cannot check “violation of any restrictions”. See your previous post: ❝ ❝ [...] check whether the subjects has not consumed any unsual diet or have ❝ ❝ followed the restrictions to be observed during the trial so that the PK ❝ ❝ profile is not altered. Diet? Intake of drugs? Both can alter the elimination (think about grapefruit juice, PK interactions). Attending a triathlon (aka strenous physical activity)? How could you confirm any of these? IMHO you would solely have to rely on asking them – and the answer is obvious. — 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 |
Ing. Helmut Schütz