Dissolution profile comparison

Regulatory pathway - specific dissolution profile similarity assessment

Make f2 similarity decisions consistent across products and teams.

FDA and EMA/ ICH M9 apply slightly different prerequisites for conventional f2 assessment of immediate - release drug products..

Paste the complete dissolution profiles. f2 Select independently applies both frameworks - screening eligibility, selecting the applicable timepoints, calculating f2 where appropriate and documenting the reasoning behind the outcome.

First full assessment is free:

For when a proposed impurity limit needs to be checked against ICH Q3A/ Q3B before it enters a specification.

For when maximum permitted % RSD for system suitability needs to be justified against pharmacopoeial expectations before the Assay method is finalised.