Interim Safety Analysis or Re-Screening [Design Issues]

posted by professionalr – India, 2025-01-09 23:56 (162 d 20:14 ago) – Posting: # 24336
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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]
—
Thanks,
RP.

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