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RegisterNo, sorry [Design Issues]
Dear Pharma_88,
Well, olaparib is to be taken every day, twice a day, and has a terminal half-life of 15 hours. How could you possibly do a single-dose BE in patients, without treatment interruption ? Even if you were to enrol patients requiring treatment and who have not started it yet, and do a 72-hour PK after their first dose: that would mean delaying the next doses, which would trigger some ethical concerns, and you would need to go for parallel design.
Well, olaparib is to be taken every day, twice a day, and has a terminal half-life of 15 hours. How could you possibly do a single-dose BE in patients, without treatment interruption ? Even if you were to enrol patients requiring treatment and who have not started it yet, and do a 72-hour PK after their first dose: that would mean delaying the next doses, which would trigger some ethical concerns, and you would need to go for parallel design.
—
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, sorryOhlbe 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, 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, sorryOhlbe 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