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Therapeutic equivalence investigations: statistical considerations
Author(s) -
Röhmel Joachim
Publication year - 1998
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/(sici)1097-0258(19980815/30)17:15/16<1703::aid-sim972>3.0.co;2-g
Subject(s) - equivalence (formal languages) , computer science , econometrics , mathematics , discrete mathematics
Therapeutic equivalence studies still present problems to regulatory reviewers from many perspectives. This paper is intended to discuss some of these concerns from the statistical viewpoint. There are, however, also some newer approaches which may be particularly useful for the investigation of therapeutic equivalence. © 1998 John Wiley & Sons Ltd.