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RegisterDeviating from a guidance [Design Issues]
Dear Helmut,
Thank you. Yes for For submission study, will definitely initiate CC with FDA. Since this is a pilot study where main objective is to assess the possibility of the single dose administration effect on pharmacokinetic as well as safety. So any possibility to conduct parallel design study? if yes, how it will be designed?
Thank you. Yes for For submission study, will definitely initiate CC with FDA. Since this is a pilot study where main objective is to assess the possibility of the single dose administration effect on pharmacokinetic as well as safety. So any possibility to conduct parallel design study? if yes, how it will be designed?
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Regards,
Pharma_88
Regards,
Pharma_88
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 guidancePharma_88 2024-05-21 08:32
- No, sorry Ohlbe 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