Date recorded: July 01 2020
How can the development viability of a new drug product or formulation be assessed? In response to the challenges associated with developing complex pharmaceutical products, the US FDA and other worldwide regulators have released product-specific guidance advising on the in vitro methods which can be applied to assess bio-availability. Targeted at enabling the rapid development of complex generic drug products, this guidance highlights the importance of assessing microstructural, or Q3, equivalence in order to ensure product performance. As a result, generic product submissions to the US FDA are at their highest level for many decades.
But is this guidance only relevant to generic drug developers? And might the scope of the methods specified be broad enough to not only show equivalence but also aid formulation optimization?
In this webinar, and the series which follows it, we will consider the role that physicochemical analysis plays in formulation development. We will introduce the micro-structural analysis toolset available from Malvern Panalytical to support in vitro bioequivalence studies. And we will then look beyond the basic guidance to consider what might be gained through targeted physicochemical analysis for both formulation and process optimization.