FDA: Mini-study (retesting) [Outliers]

posted by jag009  – NJ, 2014-05-27 23:52 (3675 d 12:37 ago) – Posting: # 13009
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Hi Helmut!

Was there a meeting in Budapest recently? Did you see Laszlo E? I had dinner with him around early May and he said he will be in Budapest...

❝ ● Performing “mini-studies” (aka retesting) was never an official recommendation. The commonly quoted sizes (at least six subjects or 20% of the main study – which ever is larger) are also an urban myth.

Nope, but you can propose.

❝ ● Some studies were quite large (60–80 subjects). When asked why they didn’t opt for reference-scaling the answer was “FDA’s guidance requires a two-way crossover!” It turned out that high variability is well documented in the literature (well, that’s why the sample size was large).

You will be surprised!

❝ ● Given the advanced technology in bioanalytics accessible today – requiring much smaller sampling volumes than a decade ago...

I've talked to some labs who still insisted "We need no less than 4 mL sample, otherwise we can't guarantee that we can do repeats"


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