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

posted by Helmut Homepage – Vienna, Austria, 2006-07-21 15:33 (6486 d 00:36 ago) – Posting: # 183
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Hello Tripathy,

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!

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