Bioequivalence and Bioavailability Forum

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