Reference ranges, prediction intervals [GxP / QC / QA]

posted by Ohlbe – France, 2020-06-22 15:38 (91 d 02:44 ago) – Posting: # 21560
Views: 398

Dear ElMaestro,

» Thinking very hard about it I have not ever seen any CRO use the prediction interval approach to define ref. ranges.

I can't remember ever seeing a path lab defining their own reference ranges: whether CRO, central lab involved in Phase III trials, or the lab next door where I had my cholesterol level measured once some years ago (I never went back: what you don't know won't hurt you). Whenever I asked, the answer was that they were taking the ranges recommended by the vendor of the machine and reagents. Which may have been determined in a rather different population on another continent.

Actually I worked for some time at a hospital lab which was involved in such an exercise on behalf of the manufacturer, to establish the normal ranges for thyroid hormones on a new lab machine. They even used a sample of my own blood (talk about freely given consent). Not sure there was much statistics involved then.

» After WHO published their rule about aberrant hemoglobin a few years back, some CROs revised their reference ranges in funny ways so that anyone on the brink of keeling over due to anemia could still be enrolled. [...] But I digress, this latter aspect is more a question of low ethical standards than a question of reference ranges.

:angry: :vomit:

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,068 posts in 4,392 threads, 1,466 registered users;
online 10 (2 registered, 8 guests [including 7 identified bots]).
Forum time: Monday 18:23 CEST (Europe/Vienna)

I have finally come to the konklusion
that a good reliable set ov bowels
iz worth more to a man
than enny quantity of brains.    Josh Billings

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5