Regulatory and Study Conditions for the Determination of Bioequivalence of Highly Variable Drugs
Purpose. The FDA Working Group on Highly Variable (HV) Drugs recently presented interim procedures and conditions for determining the bioequivalence (BE) of HV drug products. They included analysis by the method of scaled average BE (SABE), a switching coefficient of variation of CVS = 30% and a reg...
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| Main Authors: | , |
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| Format: | Book |
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Frontiers Media S.A.,
2009-05-01T00:00:00Z.
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| Call Number: |
A1234.567 |
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