Baseline correction [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2015-04-07 17:30 (4100 d 02:07 ago) – Posting: # 14672
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❝ Mr Schuetz!


Mr Teixeira! :-D

❝ ❝ Yes, but that’s a different story. If the measured concentration equals the baseline, you get after subtraction a “true” zero. Such values are valid and should be used. If C <LLOQ then force it to zero.

❝

❝ When the corrected concentration results in a negative value it makes no sense IMHO, …


What do you suggest instead?

❝ … and they ask us to force this point to zero...


I have given up monitoring ANVISA’s website, but we find such a statement in numerous of FDA’s guidances (e.g., ergocalciferol):

We recommend that applicants mea­sure and approximate the baseline endogenous levels in blood (plasma) and subtract these levels from the total concentrations mea­sured from each subject after the drug product is administered. In this way, you can achieve an estimate of BE of the products.
If a baseline correction results in a negative plasma concentration value, the value should be set equal to 0 before calculating the baseline-corrected AUC. […] Deter­mi­nation of BE should be based on the baseline-corrected data.

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