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RegisterLottery or science? [PK / PD]
Hi everybody!
Read this UK EPAR by chance, stopped on page 63, Table with CIs, including for Ctrough
click me to the EPAR
Nice example that one single concentration (maybe close to LLOQ) might mess up a whole BE-study and development program.
Is this still science or is it just some lottery (inviting for every kind of, ehhhmmm, data beautification)? This Ctrough parameter for multiple-dose studies is far from good, in my opinion... Apparently the replicate design was only chosen due to Ctrough, as Cmax showed moderate CVintra, and AUC even lower.
btw: page above:
"The elimination half life of quetiapine is approx. 7 hours. It can therefore be assumed that steady state would be reached..."
Really? Isn't it flip-flop kinetics for the PR-formulation and the IR half-life isn't interesting at all (except for absorption phase)? Just asking...
Edit: Category changed. [Helmut]
Read this UK EPAR by chance, stopped on page 63, Table with CIs, including for Ctrough
click me to the EPAR
Nice example that one single concentration (maybe close to LLOQ) might mess up a whole BE-study and development program.
Is this still science or is it just some lottery (inviting for every kind of, ehhhmmm, data beautification)? This Ctrough parameter for multiple-dose studies is far from good, in my opinion... Apparently the replicate design was only chosen due to Ctrough, as Cmax showed moderate CVintra, and AUC even lower.
btw: page above:
"The elimination half life of quetiapine is approx. 7 hours. It can therefore be assumed that steady state would be reached..."
Really? Isn't it flip-flop kinetics for the PR-formulation and the IR half-life isn't interesting at all (except for absorption phase)? Just asking...
Edit: Category changed. [Helmut]
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Lottery or science?nobody 2015-01-13 10:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Lottery or science? ElMaestro 2015-01-13 10:38
- Lottery or science? nobody 2015-01-13 10:45
- Lottery or science? ElMaestro 2015-01-13 11:05
- Lottery or science? nobody 2015-01-13 11:23
- Lottery: maybe. Science: no. Helmut 2015-01-13 13:50
- Lottery: maybe. Science: occasionally ElMaestro 2015-01-13 16:45
- Lottery: maybe. Science: occasionally nobody 2015-01-13 17:16
- Lottery: maybe. Science: no. nobody 2015-01-13 17:12
- post additional studies ElMaestro 2015-01-13 17:46
- post additional studies nobody 2015-01-13 18:28
- Historic abstract of Cmin in BE Helmut 2015-01-14 01:42
- Historic abstract of Cmin in BE nobody 2015-01-14 08:42
- post additional studies ElMaestro 2015-01-13 17:46
- Lottery: maybe. Science: occasionally ElMaestro 2015-01-13 16:45
- Lottery: maybe. Science: no. Helmut 2015-01-13 13:50
- Lottery or science? nobody 2015-01-13 11:23
- Lottery or science? ElMaestro 2015-01-13 11:05
- Lottery or science? nobody 2015-01-13 10:45
- Lottery or science? ElMaestro 2015-01-13 10:38
Ing. Helmut Schütz