A New Proposed Scaled Criterion for Drug Interchangeability
*Shein-Chung Chow, Duke University Keywords: Individual bioequivalence; Drug interchangeability; Highly variable drug products; Scaled Average Bioequivalence Criterion Criteria for assessment of bioequivalence for generic drug products are reviewed. These criteria include criterion for average bioequivalence, criteria for population and individual bioequivalence, and a recent proposed scaled average bioequivalence (SABE) criterion for highly variable drug products. In addition, following similar idea of IBE and the development of SABE, a new criterion for assessment of drug interchangeability is proposed. A numerical study was conducted to illustrate the use of the proposed criterion. In addition to the assessment of drug interchangeability for generic drug products, the proposed criterion can be applied to the assessment of drug interchangeability for biosimilar products.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC