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KR ★ India, 2013-08-17 14:07 (4285 d 15:14 ago) Posting: # 11297 Views: 6,888 |
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Hello, Please let me know the correct blood sample collection procedure for PK analysis. For example: If dosing time is 07:00 am then blood sample has to be collected at 08:00 am for 1 hour schedule time. If ±2 minutes deviation from the scheduled time is acceptable then
Thanks in advance, KR Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2013-08-17 16:49 (4285 d 12:32 ago) @ KR Posting: # 11298 Views: 5,989 |
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Hi KR, whatever you do, as long as you stick to the same procedure throughout the entire study there will be no impact on its results. Time is the independent variable in PK and – leaving some sophisticated PopPK models aside – assumed to be free of error. Therefore, it is essential to record the actual time points as exactly as possible. ❝ Which is the right practice in the industry ? There is not right or wrong. Following your example (dosing at 7:00, scheduled sample at 8:00) most people start sampling at 8:00 and record the end of sampling. BTW, some sites equipped with a barcode system connected to e.g., ClinBase™ have a time resolution of four [sic] seconds. A little bit over the top, IMHO. P.S.: Any particular reason why you posted in the Regulatives / Guidelines-category? — 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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KR ★ India, 2013-08-17 21:41 (4285 d 07:40 ago) @ Helmut Posting: # 11301 Views: 5,828 |
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Thanks Sir for prompt reply. One more question: Should we record start time of blood sample collection or end time in subject CRF? For example, if start time is 08:00 am and end time of blood sample collection is 08:02 am then what should we record as actual time in CRF. BTW: I put the comment in 'Regulatory/Guidelines' by thinking there may be any regulatory suggestion on this. Thanks again. KR |
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Dr_Dan ★★ Germany, 2013-08-19 12:54 (4283 d 16:27 ago) @ KR Posting: # 11303 Views: 5,728 |
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Dear KR As Helmut stated: First of all ensure that you stick to the same procedure throughout the entire study. I suggest to record the end time of blood drawing, since you never know how long this could last (for example if difficulties such as clotted vains occur). I hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★ Vienna, Austria, 2013-08-19 13:19 (4283 d 16:02 ago) @ Dr_Dan Posting: # 11304 Views: 5,832 |
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Dear Dan, ❝ I suggest to record the end time of blood drawing, since you never know how long this could last (for example if difficulties such as clotted vains occur). Well, this is exactly the reason I would rather opt for the end of sampling. Generally it takes less than two minutes. What if it takes five – i.e., the main part of the sample is drawn in the last two of the five due to clotting or a blocked vent flow tube? — 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 |
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Dr_Dan ★★ Germany, 2013-08-19 13:31 (4283 d 15:50 ago) @ Helmut Posting: # 11305 Views: 5,730 |
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Hi Helmut ❝ Well, this is exactly the reason I would rather opt for the end of sampling. Generally it takes less than two minutes. What if it takes five – i.e., the main part of the sample is drawn in the last two of the five due to clotting or a blocked vent flow tube? Isn't this what I said? LG Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★ Vienna, Austria, 2013-08-19 13:34 (4283 d 15:47 ago) @ Dr_Dan Posting: # 11306 Views: 5,706 |
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Der Dan, ❝ Isn't this what I said? Oh boy, I should get another — 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 |
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KR ★ India, 2013-08-20 10:33 (4282 d 18:48 ago) @ Helmut Posting: # 11311 Views: 5,702 |
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Thanks for the valuable response. KR |
Ing. Helmut Schütz