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Modern Approaches in Drug Designing

Novel Approaches of Demonstrating Bioequivalence

  • Open or Close Sarfaraz K Niazi*

    Executive Chairman, Karyo Biologics, Illinois USA

    *Corresponding author: Sarfaraz K. Niazi, Ph.D., Executive Chairman, Karyo Biologics, Hoffman Estates, Illinois, USA; Email:

Submission: October 03, 2017; Published: January 29, 2018

DOI: 10.31031/MADD.2018.01.000520

ISSN: 2576-9170
Volume1 Issue4


The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417) of 1984 have made drugs more accessible. One of the key elements of the Act is the demonstration of bioequivalence of generic products containing drugs that are not eligible for bioequivalence waiver. Bioequivalence testing originated in the early 1970s with the ±20 rule. According to a separate study, “the shortcomings of this approach were immediately evident, since such a criterion would theoretically allow the parameters of generic product A to differ from the reference (innovator) product by +20%, while allowing the parameters of generic product B to differ from the reference product by -20%.

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