Blood sample collection procedure [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2013-08-17 16:49 (4698 d 07:24 ago) – Posting: # 11298
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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?

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