Abend, Andreas, Heimbach, Tycho, Cohen, Michael, Kesisoglou, Filippos, Pepin, Xavier and Suarez, Sandra (2018) DISSOLUTION AND TRANSLATIONAL MODELING STRATEGIES ENABLING PATIENT-CENTRIC PRODUCT DEVELOPMENT M-CERSI WORKSHOP SUMMARY REPORT. American Association of Pharmaceutical Scientists Journal.

Abstract

Abstract
On May 15th -17th 2017, the US Food and Drug Administration (FDA) and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) held a workshop at the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI), Baltimore campus to discuss the role of dissolution testing and translational modeling and simulation in enabling patient-centric drug product development. This three-day event was attended by roughly 120 scientists from international regulatory agencies, major global pharmaceutical companies and academia. The recognition of patient-centric drug product development by the FDA and the scientific community is not a new concept, and yet, the number of submissions containing data that link product quality attributes to in vivo performance in order to enhance drug product understanding appears stagnant. In this regard, one of the areas of focus of the workshop was to discuss the gaps in knowledge and challenges that the scientific community is facing to establish this in vitro-in vivo link.

The first day of the meeting focused on the role of dissolution testing to guide formulation candidate selection, to assess and to mitigate biopharmaceutics risks, and as a quality control tool. On the second day, approaches to establish a link between in vitro testing and in vivo drug product performance were presented. Overall success rates and challenges in establishing in vitro – in vivo correlations (IVIVC) via traditional and modern physiologically based pharmacokinetic (PBPK) modeling and simulation approaches were discussed. Day 3 provided an opportunity for regulatory agencies and industry to discuss their expectations for establishing clinically relevant drug product specifications. After the morning presentations, afternoon breakout sessions served as platforms for the discussion of key and controversial topics.

The meeting concluded with a commitment to continue the dialogue between regulators, industry and academia to advance overall product quality understanding.

Item Type:	Article
Date Deposited:	03 May 2018 00:45
Last Modified:	03 May 2018 00:45
URI:	https://oak.novartis.com/id/eprint/34995