13AM 500x150R2 


Recent Advances in Fixed-Dose Combination Therapy

Wednesday, November 13, 2013
8:30 am–11:00 am

Overview | Hotel/Travel | Program 

ACPE Number: 0073-9999-13-545-L04-P
CE Credit Hours—2.5 hours; 0.25 CEUs


Despite the perceived complexity and challenges, fixed-dose combination (FDC) products are becoming a popular treatment option for many therapeutic areas. This is because of increased patient compliance and convenience, improved clinical effectiveness, potential reduced cost to the patient, and extension of exclusivity to pharmaceutical companies. The top five therapeutic areas for approved FDCs are infectious, cardiovascular, hormone, allergies, and pain according to Physician Desk Reference (2010). Key challenges facing this technology are reduced dosing flexibility, difficult to pinpoint potential adverse effect of drugs, as well as potential large size of the dosage form. Drug dosing and formulation design such as immediate release vs. modified release are the key factors that impact the choice of formulation technology (monolith vs. multiparticulates). There is a recent focus on bioequivalence (BE) aspects of FDC when comparing with coadministration of monotherapy and some case studies will be discussed at this mini-symposium. Significant efforts have been made by various regulatory authorities to provide guidance on bioequivalence studies and to facilitate the development of FDC products. Regulatory discussion on strategies that will help achieve product approvals by FDA will be presented. In this symposium, there will be an attempt to throw light on the formulation, clinical, and regulatory aspects of FDC products. Case studies of various therapeutic categories which have demonstrated a significant benefit from FDC products will be presented in detail. Formulation dosage design, quality by design (QbD), and manufacturing aspects of FDC products will be discussed. Expert views on the BE challenges originating from high variable drugs, metabolites, and non-linear pharmacokinetics will be presented. Additional time will be made available to share and learn amongst the attendees.

Upon completion of the symposium participants should be able to: 1) choose the most optimum formulation strategy for a FDC product; 2) identify challenges and opportunities in achieving bioequivalence for fixed-dose combination products; and 3) plan and coordinate the review process within FDA at an early stage of FDC product development.


Housing is now open for the 2013 AAPS Annual Meeting and Exposition!

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Ali Rajabi-Siahboomi, Ph.D.
VP and Chief Scientific Officer/New Product Development
Colorcon, Inc., Harleysville, Pa.

8:30 am–9:00 am
Formulation Design Considerations for Fixed-Dose Combination of Oral Solid Dosage Forms
Divyakant S. Desai, Ph.D.
Research Fellow/ Drug Product Science and Technology
Bristol-Myers Squibb Company, New Brunswick, N.J.

9:00 am–9:30 am
Bioequivalence Consideration of Fixed-Dose Combination Therapies
Amitava Mitra, Ph.D.
Principal Scientist/ Pharmaceuical Sciences
Merck & Co., Inc., West Point, Pa.

9:30 am–10:00 am
Overview of Challenges and Opportunities in Fixed-Dose Combination Therapies
Anil Kane, Ph.D., M.B.A.
Executive Director/Global Science & Technology
Patheon Inc., Durham, N.C.

10:00 am–10:30 am
Regulatory and Quality Consideration for Fixed-Dose Combinations
Mark Seggel, Ph.D. (invited)
Senior Reviewer/CDel.R
U.S. Food and Drug Administration, Silver Spring, Md.

10:30 am–11:00 am
Panel Discussion

11:00 am

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