Multiple Dose, Steady State-Partial reference replicate [Design Issues]

posted by jag009  – NJ, 2018-07-17 06:34 (799 d 04:59 ago) – Posting: # 19074
Views: 2,536

» Please help in understanding whether it is possible to conduct “An open-label, randomized, Multiple Dose, Steady State, two treatments, three periods, three sequence, three way, Reference Replicated crossover bioequivalence study” for USFDA Submission?

Why you are doing multiple dose? FDA does not like multiple dose (unless you are doing b2).


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