Outlier testing in nonreplicate studies [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2012-03-17 14:43 (4098 d 06:56 ago) – Posting: # 8292
Views: 3,576

Dear Kaushal!

❝ One BA/BE study was meeting acceptance criteria as per FDA retirement. (80-125%). IS this required to check outlier for pass bio-study?

See the 2001 guidance, VII. C. Outlier Considerations:

[…] deletion of outlier values is generally discouraged, particularly for nonreplicated designs.

Since deletion is discouraged, I would not expect FDA to ask for a check.

❝ Also if we apply outlier test for bio-study than one subject found as outlier and after excluding that subject, study goes to fail to meet acceptance criteria (80-125).

Now it gets interesting. :-D
Not specifically an FDA issue, but regulators seems to be allergic to outlier testing. At the 3rd EGA Symposium on Bioequivalence (London, June 2010) Gerald Beuerle presented an example where due to an obvious mix-up of samples between two subjects at Cmax the study would pass with the “wrong” values and fail after exchanging them (or excluding both subjects as well). Even in this case (likely BE falsely concluded) members of EMA’s PK group defended their position against testing for outliers…
Nice for the sponsor but what about patient’s risk?

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

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

Complete thread:

UA Flag
 Admin contact
22,618 posts in 4,741 threads, 1,612 registered users;
19 visitors (0 registered, 19 guests [including 11 identified bots]).
Forum time: 22:40 CEST (Europe/Vienna)

There are in fact two things, science and opinion;
the former begets knowledge, the latter ignorance.    Hippocrates

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