Bioequivalence and Bioavailability Forum

Two pilot studies (2x2) passed for AUC and Cmax, a pivotal study (4x2) failed for both AUC and Cmax (AUC and Cmax ~130%, U95%CI ~1.40). Another large scale study passed. Would like to invalidate the failed pivotal study which had significant period effects (AUC and Cmax); a significant product*period*sequence effect; significant product differences were seen in periods 1 & 3, not in 2 & 4; within sequence product differences were significant within period 1 but not in sequence 2; CV ~ 35% for both AUC and Cmax in failed study; ~ 25% in past studies. I would like to use the second large study as pivotal. How can I do this - do I need to invalidate the pivotol study.

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Edit: Category changed. Please follow the Forum’s Policy. [Helmut]