Posting: # 180
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,
Posting: # 183
and welcome to the forum!
First have a look at this thread.
Personally I don't know any US-FDA's document regarding outliers.
You may find David Dubin's post (the last one on the page) at David Bourne's list interesting.
Generally speaking the more 'outlier conditions' you can justify in the protocol, the less trouble you will experience afterwards...
Post hoc exclusion is not a good idea!
The quality of responses received is directly proportional to the quality of the question asked. ☼
Posting: # 187
Thanks for the prompt reply. I will come back to you if I have any other doubts.