, WI *This article represents the scientific opinion of many experts and, in particular, is derived from a series of workshops held under the auspices of the Federation International Pharmaceutique (FIP) and cosponsored by the Royal Pharmaceutical Society (UK), the Bundesverband der Pharmazeutischen Industrie (BPI), Colloquium Pharmaceuticum (Germany), the American Association of Pharmaceutical Scientists (AAPS, US), and the US Food and Drug Administration. It is

An overview is provided regarding the different use of in vitro dissolution and particular related regulatory aspects. The overview attempts to clarify the regulatory requirements in all contexts in which in vitro dissolution data are employed. The different areas comprise the development of new and generic products as well as bioequivalence between different formulations. In vitro dissolution is no longer one issue among others in terms of specifications and batch release only, but is aimed to be a relevant tool for describing biopharmaceutic product characteristics for different purposes in the regulatory environment. Accordingly, the extent of the experiments will depend on the purpose of the in vitro dissolution data.

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A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scientists, together with regulatory and academic scientists, came together through a series of six webinars, to discuss progress in the field, emerging trends, and areas for continued collaboration and harmonisation. Each webinar also hosted a Q&A session where participants could discuss the shared topic and information. Although it was clear from the presentations and Q&A sessions that we continue to make progress in the field of CRDSs and the utility/success of PBBM, there is also a need to continue the momentum and dialogue between the industry and regulators. Five key areas were identified which require further discussion and harmonisation.