Bioequivalence and Bioavailability Forum

When you have limited time on your side I will take the following approach

1. First take a standard drug dissolution data (Metoprolol) published in classic IVIVC papers by UMBC Natalie Eddington et. al during late 90s.

2. Use the published Metorpolol data or data available in the public domain (e.g. FDA website )and follow their outlined steps for constructing the Weibul plot applying one or two known tools (SingmaPlot, WinNonlin or Gastroplus) in addition to the DD scholar or R, then

3. Conduct a 3 or 4-way comparison of Weibull plot results to validate your DD Scholar output for metoprolol.

This comparison serves as a validation, and then repeat the exercise with your experimental data show results from your DD-scolar work compares well with reference technique.

WinNonlin IVIVC tool kit provides Model 602 as Weibul comparison.

The equation for Weibul given as

y(t) = Finf (1 - exp[-(t / MDT)b]) (ref: page 46 of 92 IVIVC help guide)



Most Importantly, A priori you have to define criteria for similar results between two methodologies (e.g. say No More than 10% difference to conclude no difference)

Hope this route helps your cause.

Best

AchievWin