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PS: No, I don't think that assay performance will do anything to intraindiv. CV of a drug product, as long as
- not practically all samples are around LLOQ
- effects are not random.
Did some sims in the old daysTM, effect of assay when validated according to current recommendations is negligible.
Especially for the "11% CV in 5 other trials, suddenly 40% in my trial" example there is no explanation remotely related to assay.
- not practically all samples are around LLOQ
- effects are not random.
Did some sims in the old daysTM, effect of assay when validated according to current recommendations is negligible.
Especially for the "11% CV in 5 other trials, suddenly 40% in my trial" example there is no explanation remotely related to assay.
—
Kindest regards, nobody
Kindest regards, nobody
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Ing. Helmut Schütz