Outliers: The FDA follows the EMA [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-03-05 01:24  – Posting: # 19999
Views: 1,351

Dear all,

on Feb 26, the FDA published a new draft Guidance

Bioavailability Studies Submitted in NDAs or INDs — General Considerations.

As usual the previous draft (of Feb 2014) was removed from the FDA’s site (still at www.regulations.gov*) but can be comfortably obtained from the [image] Internet Archive.

Interesting that between the paragraphs

Subjects with pre-dose plasma concentrations

and

Data deletion because of vomiting

there is a new one (p 27, lines 952–961):

Handling Outliers
If any data are identified as statistical outliers, sponsors should not remove the data from the statistical analysis of BA studies solely based on this fact. The only instance where outlier data can be removed from the statistical analysis of a BA study is when there is coinciding documentation demonstrating a protocol violation (e.g., real-time documentation of a sample processing error as opposed to a retrospective investigation based on the analytical results). Data from re-dosing studies are not considered as evidence to support the removal of outlier data from the statistical analysis. Data from all subjects should be submitted, and potential outliers should be flagged with appropriate documentation as part of the submission.

This is like what we have in the EU but contradicts what we discussed at the 2nd GBHI-conference in Rockville…

I expect a similar move in the ANDA-guidance.



Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,138 posts in 4,246 threads, 1,386 registered users;
online 14 (0 registered, 14 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 17:56 CET

It is better to debate a question without settling it
than to settle a question without debating it.    Joseph Joubert

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