FDA: Mini-study (retesting) [Outliers]
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"
- FDA: Mini-study (retesting) Helmut 2014-05-26 17:50
- FDA: Mini-study (retesting)jag009 2014-05-27 21:52