The approval was based on data from the phase 1 ELEVATE-PLUS trials, which showed the acalabrutinib 100mg tablets were bioequivalent to the acalabrutinib 100mg capsules. The Food and Drug ...
A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation. The reformulation of a 100-mg tablet into a 300-mgtablet ...