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

posted by ElMaestro  – Belgium?, 2018-07-13 13:42 (869 d 17:23 ago) – Posting: # 19047
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Hi arl_stat,

» 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?

Yes to everything except (conditionally) the term 'three way' in the context of your post.

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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