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Fixed Dose Combination (FDC) – A Cost Effective Approach for Simplified Dosing


Anthony Qu, Ph.D. (Vice President Scientific Affairs, Halo Pharmaceutical)

Location: 119A

Date: Wednesday, April 25

Time: 3:15pm - 4:00pm

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.

  • FDCs are normally composed of previously approved molecules. 505(b)(2) pathway is commonly used for these approvals (shorter development program). Additional IP protection and extended market shares.
  • Normally low therapeutic dose of 2 drugs and more effective than higher dose of single drug.
  • Simplified treatment regimen: better adherence and compliance.
  • Health care costs will be reduced, fewer copayments and fewer refills.
  • Manufacturing and testing cost could be lower: one drug product vs. two or three separate drug products

This session will discuss:

  • Several case studies of FDCs highlighting both adult and pediatric formulation development and innovation
  • Processing challenges associated with development of FDCs and the scientific approach to overcome those challenges

Presentation File