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RegisterOutlier consideration and re-dosing of Subjects [Regulatives / Guidelines]
Dear Forum member,
I am a Pharmacokinetist. I am new to this forum.
I went through some of the discussion topics, I found them really useful and decided to become a member of this forum.
I would like to ask forum members regarding the Statistical outlier consideration and re-dosing of subjects in a BE study. Whether outliers and re-dosing of subjects are acceptable by US-FDA regulatory, if yes then I would be very greatful to you if you provide me the link to any such guidance or correspondance from US-FDA.
Thanks and Regards,
Tripathy
I am a Pharmacokinetist. I am new to this forum.
I went through some of the discussion topics, I found them really useful and decided to become a member of this forum.
I would like to ask forum members regarding the Statistical outlier consideration and re-dosing of subjects in a BE study. Whether outliers and re-dosing of subjects are acceptable by US-FDA regulatory, if yes then I would be very greatful to you if you provide me the link to any such guidance or correspondance from US-FDA.
Thanks and Regards,
Tripathy
Complete thread:
- Outlier consideration and re-dosing of Subjectstripathy 2006-07-21 06:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outlier consideration and re-dosing of Subjects Helmut 2006-07-21 13:33
- Outlier consideration and re-dosing of Subjects tripathy 2006-07-24 05:52
- Outlier consideration and re-dosing of Subjects Helmut 2006-07-21 13:33
Ing. Helmut Schütz