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RegisterMultiple Dose, Steady State-Partial reference replicate [Design Issues]
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]
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]
Complete thread:
- Multiple Dose, Steady State-Partial reference replicatearl_stat 2018-07-13 13:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 replicate jag009 2018-07-17 06:34
Ing. Helmut Schütz