LLOQ ≤5% of average or minimal Cmax? [Bioanalytics]

posted by Beholder  – Russia, 2018-10-18 13:59 (771 d 02:01 ago) – Posting: # 19469
Views: 2,859

(edited by Beholder on 2018-10-19 08:34)

Hi Helmut,

» first of all congratulations for mastering the forum’s tricky syntax of nested lists. ;-)

THX. I reached it finally. Years passed.:-D

» AFAIK, the Russian language leaves a lot of space for interpretation. Is the common meaning of »не должен« really equivalent to “cannot” or “must not”? Since I don’t speak Russian, I have to rely on A(un)I: Google, Yandex, and Bing translate it as “should not” – which is exactly the phrase used in the EMA’s GL.

You are right regarding the meaning. Yes, it is rather "should not". But looks like I was not clear enough. I was talking about text which is marked with blue: "...(the minimum Cmax value from the entire sample of subjects)". It is one story when we take 5% from average Cmax, but it is another story when we take 5% from minimum value of Cmax in volunteers cohort. My question was caused by an article where such information was presented: "According to the literature, the minimum arithmetic average Cmax is 1,479.61 ng / ml (when taking atazanavir at a dose of 300 mg) [15]. Thus, the LLOQ should not exceed 74 ng / ml. However, it should be taken into account that, in accordance with the requirements of the EAEU, the LLOQ is calculated based on the minimum value of Cmax from the entire sample of subjects [4]. In the analyzed studies, the minimum value of Cmax was 60.8 ng / ml, while the calculated value of LLOQ is 3 ng / ml."


Edited: link to the article updated.

Best regards
Beholder

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