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FDA/PQRI Workshop: Challenges and Opportunities for Modified Release Oral Drug Product Development – A Forum for Stakeholder Engagement

An In-Person Event: April 18, 2024, Rockville, Maryland USA

Workshop Description:  This FDA/PQRI Workshop brought together leaders and subject matter experts from regulatory agencies, industry, and academia to discuss critical topics related to modified release (MR) drug products for oral administration.

This workshop aimed to facilitate interaction among stakeholders to:

      • Review recent advances in pharmaceutical science and technology for MR drug products.
      • Discuss special topics related to demonstrating BE for generic MR products.
      • Discuss current state modeling approaches for BE assessment for MR drug products to support regulatory approval.
      • Identify factors constituting alternative in vitro approaches to support BE for additional strengths of MR products.

WORKSHOP MATERIALS

A final program is available to download here. (As of 4/13/24)

Workshop speaker/moderator/panelist bios are available here.

Logistics for the workshop are available to download here.

A Workshop Flyer is available to download and share with your interested colleagues.

QUESTIONS?

Please contact the PQRI Secretariat if you have any questions, at +1(202) 230-5607 or PQRISecretariat@pqri.org.

Product Quality Research Institute
1500 K Street, N.W., 4th Floor, Washington, DC 20005-1209, USA
202-230-5199, Fax: 202-842-8465 Email PQRI

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