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The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research‐based pharmaceutical company
Author(s) -
Hauschke Dieter,
Steinijans Volker W.
Publication year - 2000
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/1097-0258(20001030)19:20<2769::aid-sim544>3.0.co;2-8
Subject(s) - bioequivalence , equivalence (formal languages) , population , econometrics , operations research , actuarial science , computer science , economics , medicine , mathematics , pharmacology , environmental health , discrete mathematics , bioavailability
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. Copyright © 2000 John Wiley & Sons, Ltd.