Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives
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 devel...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2019-12-01
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| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/12/1/19 |
| _version_ | 1798042428008038400 |
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| author | Mark McAllister Talia Flanagan Karin Boon Xavier Pepin Christophe Tistaert Masoud Jamei Andreas Abend Evangelos Kotzagiorgis Claire Mackie |
| author_facet | Mark McAllister Talia Flanagan Karin Boon Xavier Pepin Christophe Tistaert Masoud Jamei Andreas Abend Evangelos Kotzagiorgis Claire Mackie |
| author_sort | Mark McAllister |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T22:35:23Z |
| format | Article |
| id | doaj.art-d563840c12884c1e841c153027ac2f11 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-11T22:35:23Z |
| publishDate | 2019-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-d563840c12884c1e841c153027ac2f112022-12-22T03:59:14ZengMDPI AGPharmaceutics1999-49232019-12-011211910.3390/pharmaceutics12010019pharmaceutics12010019Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory PerspectivesMark McAllister0Talia Flanagan1Karin Boon2Xavier Pepin3Christophe Tistaert4Masoud Jamei5Andreas Abend6Evangelos Kotzagiorgis7Claire Mackie8Pfizer PGRD, Sandwich CT13 9NJ, UKAstraZeneca UK Limited, Macclesfield SK10 2NA, UKLicensing Division, MHRA, London E14 4PU, UKAstraZeneca UK Limited, Macclesfield SK10 2NA, UKJanssen Research and Development, 2340 Beerse, BelgiumCertara UK, Simcyp Division, Sheffield S1 2BJ, UKMerck & Co., Inc., West Point, PA 19486, USAEuropean Medicines Agency, 1083 HS Amsterdam, The NetherlandsJanssen Research and Development, 2340 Beerse, BelgiumA 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.https://www.mdpi.com/1999-4923/12/1/19oraldrug productsclinically relevant dissolution specificationspbbmproduct performancebiorelevant dissolution |
| spellingShingle | Mark McAllister Talia Flanagan Karin Boon Xavier Pepin Christophe Tistaert Masoud Jamei Andreas Abend Evangelos Kotzagiorgis Claire Mackie Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives Pharmaceutics oral drug products clinically relevant dissolution specifications pbbm product performance biorelevant dissolution |
| title | Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives |
| title_full | Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives |
| title_fullStr | Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives |
| title_full_unstemmed | Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives |
| title_short | Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives |
| title_sort | developing clinically relevant dissolution specifications for oral drug products industrial and regulatory perspectives |
| topic | oral drug products clinically relevant dissolution specifications pbbm product performance biorelevant dissolution |
| url | https://www.mdpi.com/1999-4923/12/1/19 |
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