In response to the challenges associated with developing complex pharmaceutical products, the US FDA and other regulators around the world have released product-specific guidance advising which in vitro methods can be applied to assess bioavailability. Intended to enable 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? Or, might the scope of the methods specified be broad enough to 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 microstructural 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.
We’ll also introduce you to the range of physicochemical measurement methods available from Malvern Panalytical and Concept Life Sciences for assessing the microstructure of pharmaceutical formulations.
Paul Kippax Ph.D. - Materials Characterization Expert and Segement Marketing Director - Pharma Division
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- Who should attend?
- Researchers considering the requirements for formulation characterization and optimization
- Formulation scientists engaged in developing candidate drug product formulations
- Analytical scientists engaged in supporting in vitro bioequivalence studies
- Laboratory managers looking to understand the techniques required to support deformulation and in vitro bioequivalence assessments
- What will you learn?
- The physiochemical properties currently highlighted as important for in vitro bioequivalence studies
- What Q3 microstructural equivalence is, and how it is important in understanding formulation performance and showing bioequivalence in vitro
- The range of physicochemical measurement methods available from Malvern Panalytical and Concept Life Sciences for assessing the microstructure of pharmaceutical formulations