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

posted by arl_stat – India, 2018-07-13 13:26 (1242 d 02:42 ago) – Posting: # 19046
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Greetings to all.

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?

Kindly share any reference article if any.

Thank you !!!


Edit: Category changed; see also this post #1[Helmut]

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