Clinical Relevance of Dissolution Testing in Quality by Design

Quality by design (QbD) has recently been introduced in pharmaceutical product development in a regulatory context and the process of implementing such concepts in the drug approval process is presently on-going. This has the potential to allow for a more flexible regulatory approach based on understanding and optimisation of how design of a product and its manufacturing process may affect product quality. Thus, adding restrictions to manufacturing beyond what can be motivated by clinical quality brings no benefits but only additional costs. This leads to a challenge for biopharmaceutical scientists to link clinical product performance to critical manufacturing attributes. In vitro dissolution testing is clearly a key tool for this purpose and the present bioequivalence guidelines and biopharmaceutical classification system (BCS) provides a platform for regulatory applications of in vitro dissolution as a marker for consistency in clinical outcomes. However, the application of these concepts might need to be further developed in the context of QbD to take advantage of the higher level of understanding that is implied and displayed in regulatory documentation utilising QbD concepts. Aspects that should be considered include identification of rate limiting steps in the absorption process that can be linked to pharmacokinetic variables and used for prediction of bioavailability variables, in vivo relevance of in vitro dissolution test conditions and performance/interpretation of specific bioavailability studies on critical formulation/process variables. This article will give some examples and suggestions how clinical relevance of dissolution testing can be achieved in the context of QbD derived from a specific case study for a BCS II compound

Translational medicine definition by the European Society for Translational Medicine

Progress in the field of translational medicine (TM) within the last decade attests to the importance of the TM initiative in the context of more traditional academic health science centers. In many instances, these advancements have taken place without a clear definition of TM, which signifies the urgent need for a clear, consensus definition that would serve as an integrative blueprint for the various “versions” of TM definition. The various existing definitions are reflecting the diversity of institutional translational research and deployment programs. The European Society for Translational Medicine (EUSTM) is a global non-profit and neutral society whose principal objective is to enhance world-wide healthcare through the specific development and eventual clinical implementation and exploitation of TM-based approaches, resources and expertise. In this position article, the EUSTM defines TM as an interdisciplinary branch of the biomedical field supported by three main pillars: benchside, bedside and community. The goal of TM is to combine disciplines, resources, expertise, and techniques within these pillars to promote enhancements in prevention, diagnosis, and therapies. Accordingly, TM is a highly interdisciplinary field, the primary goal of which is to coalesce assets of various natures within the individual pillars in order to improve the global healthcare system significantly