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Quality by Design: Next Steps to Realize Opportunities? - page 16 / 37

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Failure to Discriminate Between Bio-in-equivalent Products: Inappropriate Acceptance Criteria

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USP Specification

Product A

Product B

Time in Minutes

Product B was not

bioequivalent to

Product A

Log(AUCinf): CI 94.6 - 123.6

Log(AUC): CI 89.1 - 130.0

Cmax: CI 105.3 - 164.2

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