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Open AccessMeeting Report

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

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Pfizer PGRD, Sandwich CT13 9NJ, UK
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AstraZeneca UK Limited, Macclesfield SK10 2NA, UK
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UCB Pharma SA, 1420 Braine l’Alleud, Belgium
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Licensing Division, MHRA, London E14 4PU, UK
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Janssen Research and Development, 2340 Beerse, Belgium
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Certara UK, Simcyp Division, Sheffield S1 2BJ, UK
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Merck & Co., Inc., West Point, PA 19486, USA
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European Medicines Agency, 1083 HS Amsterdam, The Netherlands
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Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(1), 19; https://doi.org/10.3390/pharmaceutics12010019
Received: 3 December 2019 / Accepted: 12 December 2019 / Published: 23 December 2019
A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that were involved in product development shared their experiences with in vitro dissolution and in silico modeling approaches to establish clinically relevant dissolution specifications. The regulators shared their perspectives on the acceptability of these different strategies for the development of acceptable specifications. The meeting also reviewed several collaborative initiatives that were relevant to regulatory biopharmaceutics. Following the scientific presentations, a roundtable session provided an opportunity for delegates to discuss the information that was shared during the presentations, debate key questions, and propose strategies to make progress in this critical area of regulatory biopharmaceutics. It was evident from the presentations and subsequent discussions that progress continues to be made with approaches to establish robust CRDS. Further dialogue between industry and regulatory agencies greatly assisted future developments and key areas for focused discussions on CRDS were identified. View Full-Text
Keywords: oral; drug products; clinically relevant dissolution specifications; PBBM; product performance; biorelevant dissolution oral; drug products; clinically relevant dissolution specifications; PBBM; product performance; biorelevant dissolution
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McAllister, M.; Flanagan, T.; Boon, K.; Pepin, X.; Tistaert, C.; Jamei, M.; Abend, A.; Kotzagiorgis, E.; Mackie, C. Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives. Pharmaceutics 2020, 12, 19.

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