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The Academy of Pharmaceutical Sciences organises several major conferences and symposia each year on topics of interest to pharmaceutical scientists. These symposia are held at different venues throughout the UK.
APS Developing Clinically Relevant Dissolution Specifications for Oral Drug Products - Industrial and Regulatory Perspectives
APS Biopharmaceutics and Regulatory Sciences Joint Meeting

Friends House, London
Tuesday 7 November 2017

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This meeting will bring together industrial scientists from multi-disciplinary drug product development teams with regulatory scientists and reviewers to discuss new approaches to develop clinically relevant dissolution specifications for oral drug products. Dissolution testing is the definitive approach to establish the impact of formulation and manufacturing process changes during oral drug product development. Effective strategies for dissolution method development and to establish relevant acceptance criteria are both essential to ensure drug product quality. Currently, during late-stage drug product development, formulation and process parameters are varied to produce so-called ‘aberrant’ formulations which are used to test the ability of a dissolution method to detect changes in oral drug product performance and then often verified in vivo. However, the approaches adopted to create formulations variants which can be considered clinically relevant can be quite diverse and regulatory guidelines for this type of experimentation are not yet clearly defined. Recent advances with in silico mechanistic absorption/PBPK modelling have increased our understanding of in vivo drug product performance and are being used increasingly to support dissolution method development and to establish clinically relevant specifications. This has highlighted the requirement for clinically relevant/biorelevant dissolution data to support model development and the need to increase the general level of understanding and confidence in the modelling of oral drug product performance for this purpose. This meeting is intended to contribute to the longer-term goal of the development of a regulatory framework to encompass this rapidly growing field.

This meeting will share case studies from industry which describe the approaches used for several oral drug products and feedback on how these were reviewed during regulatory interactions. Regulatory perspectives will be provided by regulatory scientists from different agencies and the agenda will also review the collaborative initiatives in regulatory biopharmaceutics such as ICH M9 which are relevant to this area. Finally, there will be an overview from the IMI OrBiTo programme which will describe a number of industrial approaches which combine the use of in vitro biorelevant dissolution with PBPK modelling to justify clinically relevant dissolution specifications. The meeting will conclude with a roundtable session to review the information shared and debate the options to move this area of regulatory biopharmaceutics forward in the future.

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