100% raw data presentation in BA report [Bioanalytics]

posted by jag009  – NJ, 2018-05-18 18:23 (2221 d 12:44 ago) – Posting: # 18784
Views: 3,252

Hi,

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.

Thanks
John

Complete thread:

UA Flag
Activity
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
136 visitors (0 registered, 136 guests [including 64 identified bots]).
Forum time: 07:07 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

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