Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2020-07-20 10:52 (23 d 18:35 ago) – Posting: # 21758
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Hi ElMaestro,

» Even back then, when dinosaurs were roaming the jungle, Lucy was still not born, TV shows about the Kardasians were in black and white, flint axes were popular etc,…

May I clarify the “etc.” partly? When I was barefooted dressed in furs and estimated rate constants from concentrations plotted on semi-log paper by means of a transparent ruler, a blinded review of data was common and excluding not plausible values was the rule rather than an exception.

If you have the stamina to watch the recordings mentioned there (navigate to 02:00:00): One participant asked “We all have seen concentrations which are ten times higher than adjacent ones. You can repeat the value a hundred times and will always get the same result. Is it possible to use M&S to justify exclusion?” Note that they were talking about a full-blown PopPK model and not just a simple lin-log regression and the likes. The answer of a guy of the FDA was in the spirit of [image] Little Britain’s Vicky:

[image]

See also my post above.

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