100% raw data presentation in BA report [Bioanalytics]

posted by jag009  – NJ, 2018-05-18 16:23 (1347 d 21:03 ago) – Posting: # 18784
Views: 2,473

(edited by jag009 on 2018-05-18 16:34)


Does anyone know what items are required to be presented in the "100% Raw data" tables in a BA report (For FDA)? Is there such a list of required items?

The reason I asked is because I have came across reports from several labs and they don't have the same # of items presented in this "100% raw data" table. Of course the crucial ones are presented, but some such as dilution factor, analysis date, IS and analyte retention times are absent from the tables generated by some labs.


Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Tuesday 12:26 CET (Europe/Vienna)

I love deadlines.
I love the whooshing sound they make
as they go by.    Douglas Adams

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