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A Two‐stage Procedure with Controlled Error Probabilities for Testing Bioequivalence
Author(s) -
Srinivasan R.,
Langenberg P.
Publication year - 1986
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.4710280708
Subject(s) - bioequivalence , statistics , mathematics , computer science , random variate , medicine , random variable , pharmacokinetics , pharmacology
The procedures currently used for testing the bioequivalence of two drug formulations achieve control over the error probability of erroneously accepting bioequivalence or over the probability of erroneous rejection, but not over both error probabilities. A two‐stage procedure that rectifies this drawback is presented, assuming that the performance of the drug is characterized by a normally distributed variate.