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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series
Mark McAllister1, Talia Flanagan2, Susan Cole3
1Pfizer WWRD, Sandwich, Kent CT13 9NJ, UK.
Pharmaceutics
|May 28, 2022
Summary
Pharmaceutical scientists discussed challenges in developing clinically relevant dissolution specifications (CRDSs) for oral drugs. Continued dialogue between industry and regulators is crucial for harmonizing standards and advancing drug development.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Biopharmaceutics
Background:
- A 2021 webinar series convened experts to address challenges in establishing clinically relevant dissolution specifications (CRDSs) for oral drug products.
- The series focused on progress, emerging trends, and collaboration opportunities in biopharmaceutics and dissolution testing.
Framework:
- The webinars facilitated discussions on the utility and success of performance-based, mechanistic modeling (PBBM) in drug development.
- Key areas requiring further discussion and harmonization were identified to advance the field.
Implementation:
- Industrial, regulatory, and academic scientists participated in six webinars, each including a Q&A session.
- Discussions aimed to foster collaboration and harmonize approaches to dissolution specifications.
Implications:
- Progress has been made in CRDSs and PBBM, but ongoing dialogue between industry and regulators is essential.
- Five key areas were identified for continued focus and harmonization to improve drug product development and regulatory alignment.
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