No, sorry [Design Issues]

posted by Ohlbe – France, 2024-05-21 14:41 (28 d 21:39 ago) – Posting: # 24006
Views: 1,108

Dear Pharma_88,

❝ Thank you for response. Could you please let me know how the parallel design will be planned?


No. I did mention parallel design, as this was the only option I could see with a single-dose administration rather than a steady-state study, but I would certainly not advise to do it. The FDA "recommends" a crossover steady-state study for good reasons.

Regards
Ohlbe

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