09. November 2017

This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps.

12. September 2017

Abstract There has been significant growth in the use of modeling tools to accelerate development and enhance pharmaceutical quality. Among these are empirical and semi-empirical modeling of accelerated stability studies which can be used to predict product shelf-life (Waterman, Pharm Res 24:780–790, 2007; (Wu et al., AAPS Pharm Sci Tech,16:986–991, 2016); (Lavrich, Rapid Development of Robust Stability Models Using Semi-Empirical Design Space, AAPS Webinar, 2016)). These approaches coupled...