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RegisterInterim Safety Analysis or Re-Screening [Design Issues]
Hi all,
We are planning to conduct a bioequivalence study for submission in Egypt. The molecules of interest necessitate a washout period of approximately three months in a crossover design. Should we perform re-screening/interim safety analysis before the dosing of Period II?
Edit: Category changed; see also this post #1. [Helmut]
We are planning to conduct a bioequivalence study for submission in Egypt. The molecules of interest necessitate a washout period of approximately three months in a crossover design. Should we perform re-screening/interim safety analysis before the dosing of Period II?
Edit: Category changed; see also this post #1. [Helmut]
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Thanks,
RP.
Thanks,
RP.
Complete thread:
- Interim Safety Analysis or Re-Screeningprofessionalr 2025-01-09 22:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Interim Safety Analysis or Re-Screening drgunasakaran1 2025-01-10 00:01
Ing. Helmut Schütz