Bioequivalence and Bioavailability Forum

Another story! [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2014-11-27 15:21 (3832 d 12:08 ago) – Posting: # 13934
Views: 14,056

Hi Emrah,

❝ The previous values were from another study.

Yes, but it would have been nice to understand what was going on there.

❝ Here are the values from the current study and the thing you ask for.

❝ Conc: 0.00

❝ Re-analysis 1: 2.63

❝ Re-analysis 2: 2.15

❝ Means of Reanalyses: 2.39

❝ Reported Conc: NR

OK, another story. Conc = 0 post dose? I don’t believe it. Rather BLQ at 72 hours. Did the CRO report other concentrations as zero?



Why was the sample at 72 hours re-analysed? Without the 72 h-value the esti­mate of the elimination is not perfect, but acceptable (or has the CRO another stupid rule like “R²_adj ≥0.95” in place?). From it we could expect the concen­tra­tion at 72 hours to be <LLOQ (~0.80). On the other hand it looks like the drug follows a two-compartment model. It would have been nice to have a sampling time at ~16 h. Based on the 24/48-concentrations the repeated values at 72 h seem to be reasonable.
But actually it is not important. The extrapolated part is <5% of AUC_∞. I don’t get why the CRO repeated the value at all.

❝ ❝ ❝ It is reported as "Fault in the sample processing".

❝ ❝ OK, but how can you know that? Was anything documented in the lab journal like “I’m not sure whether I added the IS to this sample”?

❝ I guess I wont be able to access lab journals.

If you are the sponsor of the study perform an audit. If the CRO is not willing to show you the lab journals never do a study with them again.

❝ Flow Chart states that If duplicates differ from each other more than 20%, the next step is checking whether difference between each duplicate and original is more than 20%. According to Lab, the difference is more than %20 and hence the value is "NR". But in my opinion it is "Not Applicable" to find the percent difference from a value of "0.00"

All these flow-charts are crap anyway, IMHO.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:25 
  • Handling "Not Reportable" Data ElMaestro 2014-11-21 07:34
    • Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:54
      • Handling "Not Reportable" Data nobody 2014-11-21 08:07
        • Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 08:18
          • Handling "Not Reportable" Data ElMaestro 2014-11-21 09:53
          • Handling "Not Reportable" Data nobody 2014-11-21 11:11
            • Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 16:14
              • IS carry-over? Helmut 2014-11-21 16:45
                • IS carry-over? nobody 2014-11-21 17:19
                • IS carry-over? Emrah Soner Özdeş 2014-11-24 08:58
                • IS carry-over? Emrah Soner Özdeş 2014-11-27 10:28
                  • Another story!Helmut 2014-11-27 14:21
                    • Another story! Emrah Soner Özdeş 2014-11-28 10:00
                    • Another story! nobody 2014-11-28 10:18
      • Handling "Not Reportable" Data AngusMcLean 2014-11-28 19:09
        • EMA and similar regulations… Helmut 2014-11-28 19:16
          • EMA and similar regulations… jag009 2014-12-01 19:54