Bioequivalence and Bioavailability Forum

Hi Imph,

❝ In bioequivalence studies, is there a way to keep the blind on the analysts in charge of the pharmacokinetic and statistical analysis ?

Yes and no.

❝ If so, is there a possibility of launching an NCA and bioequivalence analysis on the Phoenix WinNonlin software while maintaining the blind.

Sure – that’s the way I do it for years. In the NCA setup Sort by subject, period. Once you are done, Merge or Join the results with the randomization-table.

Hi Imph,

❝ In bioequivalence studies, is there a way to keep the blind on the analysts in charge of the pharmacokinetic and statistical analysis ? If so, is there a possibility of launching an NCA and bioequivalence analysis on the Phoenix WinNonlin software while maintaining the blind.

What an interesting and atypical question. Thank you.
I do no know about WinNonlin at all, but this detail aside the matter poses no particular difficulties. You could have an automated process started by a project manager (or whoever ) where stats software queries the PK listing along with the rand. code from separate locations, processes the data and saves the outcome without the statistical or the PK staff even knowing it has taken place.
If WNL can be run from command line (why shouldn't it?) then all this is will be fairly easy to do:

Person A saves bioanalytical data in folder X. Write access only.
Person B saves Rand Code in folder Y. Write access only.
Person C shell executes WNL (read access to X and Y) to reconcile PK data with RC, and run the analyses and saving it in location Z while revoking A+B writing credentials (write access).

This could be a very, very safe and advantageous approach (one that even could be combined with signal detection etc). But of course if there is an issue with the files and WNL is stuck, then some intervention could be needed.