Outlier consideration and re-dosing of Subjects [Regulatives / Guidelines]

posted by tripathy – 2006-07-21 06:06  – Posting: # 180
Views: 5,028

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

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