Outlier consideration and re-dosing of Subjects [Regulatives / Guidelines]
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!
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!
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Outlier consideration and re-dosing of Subjects tripathy 2006-07-21 06:06
- Outlier consideration and re-dosing of SubjectsHelmut 2006-07-21 13:33
- Outlier consideration and re-dosing of Subjects tripathy 2006-07-24 05:52
- Outlier consideration and re-dosing of SubjectsHelmut 2006-07-21 13:33