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Abstract
Modern Approaches in Drug Designing
Novel Approaches of Demonstrating Bioequivalence
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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
Submission: October 03, 2017; Published: January 29, 2018
ISSN: 2576-9170Volume1 Issue4
Abstract
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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