The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company.
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.
Hauschke
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D
Department of Biometry, Byk Gulden Pharmaceuticals, Byk-Gulden-Str. 2, 78467 Konstanz, Germany. dieter.hauschke@byk.de
Steinijans
V W
VW
D002626:Chemistry, Pharmaceutical; D017408:Guidelines as Topic; D006801:Humans; D015233:Models, Statistical; D012107:Research Design; D018401:Sample Size; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration