Abstract
AbstractThe two one-sided tests (TOST) method for mean equivalence or average equivalence has been extended to assessing similarity or switchability for individual equivalence in clinical trials. Tolerance interval procedures are available to establish similarity with respect to the proportion of the response differences covered by a prespecified threshold range. However, the extended TOST procedures based on tolerance intervals are potentially susceptible to the control of Type I errors. This article aims to present an exact approach with the specified Type I error probability for appraising similarity between two treatments in comparative studies with heterogeneous variances. Analytic examination and numerical comparison are conducted to clarify the utility of the suggested similarity test and the drawback of the current TOST procedures. To enhance the usefulness of the described exact method, the related power and sample size issues are also considered. Computer algorithms are provided to implement the proposed test procedure, power calculation, and sample size determination in similarity studies.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
