EU: no re-dosing [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2011-03-09 13:40 (4768 d 08:21 ago) – Posting: # 6732
Views: 7,791

Dear Swapnil!

❝ Due to one outlier subject one of our pivotal study is failing.


How did you judge that the subject was an outlier?

❝ In such case can we perform redosing for approximately 20% (of original sample size) subjects to confirm the results and to support our application (MA).


Sometimes. You are aware that FDA hates such an approach and it should not be considered standard?

❝ Nowadays this approach is used for USFDA but can you please update me regarding EU view on the same.


Re-dosing is not acceptable in the EU. Sorry.

Reasons for exclusion must be pre-specified in the protocol. Besides clinical events (vomiting, diarrhoea,…), PK reasons are:(my emphases)

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
79 visitors (0 registered, 79 guests [including 8 identified bots]).
Forum time: 22:02 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5