Collaboration among disciplines is essential.
By Xujin Lu, Ph.D., Bristol-Myers Squibb; Jian-Hwa Han, Ph.D., Abbvie; Danna Mattocks, TherapeuticsMD; and David Curran, GlaxoSmithKline
Since biorelevant dissolution and clinically relevant specifications became hot topics,1 the following question has been posed: When biorelevant methods are established for formulation development, why aren’t they used as the registered quality control (QC) method? To answer this question, both current industry practice and the gap between in vitro dissolution testing and in vivo drug performance were evaluated.