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

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

posted by jag009 – NJ, 2018-07-17 08:34 (1904 d 11:18 ago) – Posting: # 19074
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❝ 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).

J

Complete thread:

Multiple Dose, Steady State-Partial reference replicate arl_stat 2018-07-13 13:26 [Design Issues]
- Multiple Dose, Steady State-Partial reference replicate ElMaestro 2018-07-13 13:42
- Logistic nigthmare Helmut 2018-07-13 14:35
- Multiple Dose, Steady State-Partial reference replicatejag009 2018-07-17 06:34