Bioequivalence and Bioavailability Forum 13:16 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

jag009
Hero

NJ,
2018-05-18 16:23
(edited by jag009 on 2018-05-18 16:34)

Posting: # 18784
Views: 848
 

 100% raw data presentation in BA report [Bioanalytics]

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
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-05-18 16:57

@ jag009
Posting: # 18787
Views: 732
 

 100% raw data presentation in BA report

Hi John,

» 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?

FDA – no idea.
In the EU inspectors love to see the time of analysis of each sample (in order to check whether the batch was interrupted and/or the validated bench-top/autosampler stability exhausted). Hence, a table with these columns:

sample № – timestamp – subject id – sample № / period (or: scheduled time) – period – concentration

If’ve seen ones where the dilution factor or alternatively a lower sample volume (if validated) is given in an additional column. Never saw retention times in any table. 20% of chromatograms are mandatory over here and nowadays most CROs provide 100% anyway. If an assessor is interested in the RTs (s)he can look it up there.

» […] 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.

OK, that’s a different story. Never seen a single table including everything (would be confusing – at least for me). Generally different ones:
  • Results of unknows (as above)
  • Calibrators
  • QC samples
  • Repeats
  • ISR

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
ElMaestro
Hero

Denmark,
2018-05-18 19:22

@ jag009
Posting: # 18788
Views: 721
 

 100% raw data presentation in BA report

Hi Jag,

» 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?

I agree with the above. There is no good definition of 100% raw data.
The problem is not only "100%" but also "raw".

In a standard LC-MS/MS setup the raw data (what the data acquisition card is measuring) is a current at a voltage sampled every dt milliseconds. That voltage is the raw data. It is converted directly (linearly, 1:1) into cps. From this everything else is derived. On top of that is the audit trail (whodunnit, and when, and why) and meta data like bunching, smoothing, and weird stuff.
It is my belief that if you list data that allow a full reconstruction of Conc versus time for all subjects (all injections) then you are meeting FDA's expectations. Most CROs do this without really listing full result tables in the reports, but some even do that.
There is no list; try and look what is fed into the cdisc files from different CROs :-)

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
jag009
Hero

NJ,
2018-05-24 03:20

@ ElMaestro
Posting: # 18809
Views: 483
 

 100% raw data presentation in BA report

Thank you guys.
John
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,697 posts in 3,982 threads, 1,230 registered users;
online 22 (0 registered, 22 guests [including 14 identified bots]).

I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauß

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