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

posted by ElMaestro - Denmark, 2018-07-13 13:42  - 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.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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