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The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based
1Department of Biometry, Byk Gulden Pharmaceuticals, Byk-Gulden-Str. 2, 78467 Konstanz, Germany. dieter.hauschke@byk.de
Statistics in Medicine
|October 18, 2000
Abstract:
Generally, the motivation for switching from average bioequivalence to population and/or individual bio-equivalence is well recognized in the light of certain limitations of the concept of average bioequivalence. However, this switch still results in unresolved issues which should be addressed before the regulatory guidance is finalized.