Bioequivalence and Bioavailability Forum

Dear ElMaestro, Detlew, and John,

THX for sharing your experiences & thoughts!

@ElMaestro: I would not audit the study. We can expect such values due to the variability close to the LLOQ (see this post). In the good ol’ days of common sense one would have reanalysed the sample in duplicate and likely the original value would have turned out to be an artifact. Only for EMA & TGA according to the current GLs such a procedure is taboo.

@Detlew: Like you I have this rule in place for ages. As I said there I never got a question. Hasn’t changed ever since. Good to know that your response was accepted.

@John: I was suspecting something along those lines from NDAs/ANDAs accessible under FOI. Many studies reported a smaller sample size for AUC_∞ than for AUC_t.