Bioequivalence and Bioavailability Forum

Thanks Ohlbe,

❝ The FDA have just published their revised guideline on bioanalytical method validation.

for this document.

Now a million dollar question:
Are you on basis of the wording on page 13 allowed to do a repeat analysis as part of an investigation? Is for example absent or low IS response (without obvious poor chromatography) itself an assignable cause? If it is, then that would negate the need for an investigation, right?

If taken literally I am inclined to think the guidance does not allow repeats as part of investigations (to me, investigations are done when root causes are not known but potential root causes are being sought).
Common sense takes me a bit in the opposite direction and I would any day prefer to talk about reported repeats and unreported repeats on basis of the presence of a cause.