Bioequivalence and Bioavailability Forum • Multiple Dose, Steady State-Partial reference replicate

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

posted by ElMaestro – Denmark, 2018-07-13 15:42 (2106 d 21:06 ago) – Posting: # 19047
Views: 3,996

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.

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Pass or fail!
ElMaestro

Complete thread:

Multiple Dose, Steady State-Partial reference replicate arl_stat 2018-07-13 13:26
- Multiple Dose, Steady State-Partial reference replicateElMaestro 2018-07-13 13:42
- Logistic nigthmare Helmut 2018-07-13 14:35
- Multiple Dose, Steady State-Partial reference replicate jag009 2018-07-17 06:34