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RegisterNo, sorry [Design Issues]
Dear Pharma_88,
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.
❝ 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
Regards
Ohlbe
Complete thread:
- Single dose PK study on Patients Pharma_88 2024-05-15 05:37 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
- Single dose PK study on Patients Pharma_88 2024-05-17 10:06
- No, sorry Ohlbe 2024-05-17 13:45
- No, sorry Pharma_88 2024-05-20 06:50
- Deviating from a guidance Helmut 2024-05-20 07:57
- Deviating from a guidance Pharma_88 2024-05-21 08:32
- No, sorryOhlbe 2024-05-21 12:41
- Deviating from a guidance Helmut 2024-05-20 07:57
- No, sorry Pharma_88 2024-05-20 06:50
- No, sorry Ohlbe 2024-05-17 13:45
- Single dose PK study on Patients Pharma_88 2024-05-17 10:06
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
Ing. Helmut Schütz