Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ So I wonder wouldn't it be very solid and a good idea to simply perform some degree of PQ "every day" or "immediately before" a reported analysis; […]

I like the idea very much!

❝ No?

Yes!

To the right one of the RSABE-templates* we developed last year. Both reference datasets from EMA’s Q&A-document are part of the pro­ject-file. It’s foolproof (I hope):
Two PDFs are directly accessible: The Q&A itself and a step-by-step instruction how to import data, map variables, perform the ana­lysis, …

After entering #1-3 in the Data-section, in #4 of the Workflow the desired dataset is chosen. Run EMA’s examples first. There is a table in the out­put where the actual results can be com­pared to the ones reported by the al­mighty oracle.

• If they match, ☑ your form, date and sign it. I would suggest to print out the result table with a timestamp as well. Proceed with your own data.
  
• If not, inhale/exhale three times slowly. Count to ten. Open the console and type format c: /q|y ⏎. Trash the machine.

It’s straightforward to set up a similar template for 2×2 cross-overs containing our reference datasets. No big deal.

❝ […] if the results match conclude that the system is PQ that day and run the necessary analysis?

I guess in any software one could modify the code after the check and before the analysis, right? But that’s plain fraud and not the topic of this thread.

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• Henry A, Schütz H, Hughes L, Davis S. Performing Reference-Scaled Average Bioequivalence (RSABE) in Phoenix^® WinNonlin^®. AAPS Annual Meeting and Exposition. 2013; Poster T2350. doi:10.13140/RG.2.1.1008.0800. download.
  Templates for Phoenix/WinNonlin 6.3+
  If you have enough stamina watch this 57 minute video.