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RegisterOutlier PK Study – Non Normal Distribution [Regulatives / Guidelines]
HI
Check previous post about what to do with outliers. I don't know the current view of the regulatory agency (FDA). I have heard that they don't accept re-dosing studies anymore (rumors).
1) Please revisit why PK parameters (AUC, Cmax) need to be logs transformed.
2) My answer to your question is no. Others might have different views.
J
❝ The thing is in my understanding it is not accepted to exlude a subject after the bioanalysis. How can we argue an outlier?
Check previous post about what to do with outliers. I don't know the current view of the regulatory agency (FDA). I have heard that they don't accept re-dosing studies anymore (rumors).
❝ It is possible to arg the distribution RLD is non mormal to file the PK report with untransformed results?
1) Please revisit why PK parameters (AUC, Cmax) need to be logs transformed.
2) My answer to your question is no. Others might have different views.
J
Complete thread:
- Outlier PK Study – Non Normal Distribution DaLoe 2017-10-19 10:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outlier PK Study – Non Normal Distributionjag009 2017-10-20 06:33
- Normal Distribution: Japan only Helmut 2017-10-23 10:25
Ing. Helmut Schütz