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Anthony Qu, Ph.D (Vice President Scientific Affairs, Halo Pharmaceutical)
Date: Wednesday, April 25
Time: 3:00pm - 3:45pm
Pass Type: Conference Pass, VIP Attendee - Get your pass now!
Track: Drug Development
Vault Recording: TBD
Fixed-dose combination products (FDCs) are the drug products containing multiple active ingredients. FDCs offer several advantages to pharmaceutical companies and patients which includes better patient compliance, more convenient dosing associated with improved clinical performance, reduce side effects, cost savings for both patients (fewer co-pays) and drug manufacturers (reduced production and testing costs), and extended patent protection. 505(b)(2) pathway is commonly used for these approvals as most of the FDCs usually consist of previously approved drugs, which leads to smaller development programs. Producing safe and effective FDC products requires thoughtful product design, access to state-of-the-art manufacturing technology, and advanced analytical tools.
This session will discuss: