Bioequivalence and Bioavailability Forum 14:33 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

100% raw data presentation in BA report [Bioanalytics]

posted by jag009 - NJ, 2018-05-18 16:23  - Posting: # 18784
Views: 854

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

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,700 posts in 3,984 threads, 1,243 registered users;
online 18 (0 registered, 18 guests [including 14 identified bots]).

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed