This workshop will bring 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 aims 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.
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