NDLI: Sequential Bioequivalence Trial Designs with Increased Power and Controlled Type I Error Rates

Content Provider	Springer Nature Link
Author	Fuglsang, Anders
Copyright Year	2013
Abstract	Methods to implement two-stage designs in two-treatment, two-sequence, and two-period crossover bioequivalence studies have only recently been developed. The two-stage methods have so far only been described for a targeted study power of 80%. Since it is sometimes desirable to increase the targeted power to 90%, this study identifies sets of alphas that work for the recently developed two-stage methods while controlling type I error rates around 5% for assumed geometric mean test/reference ratios of 0.90 and 0.95 at targeted power of 90%, and provides a characterization of the methods in terms of the resulting sample sizes and power. Depending on the actual variability and the chosen sample size at stage 1, the actual power will be between 83% and 100%. The previously characterised methods at target power 80% as well as 90% result in trivial inflation of type 1 error, but the type 1 error inflation at 90% target powers with decreased alpha at the second stage result in slightly less inflation. These results may be useful for applicant wishing to achieve increased power in bioequivalence trials without a penalty for type I error rates.
Starting Page	659
Ending Page	661
Page Count	3
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	15
Issue Number	3
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2013-03-30
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	bioequivalence dry powder inhalers power sequential designs type I errors Pharmacology/Toxicology Biochemistry Biotechnology Pharmacy
Content Type	Text
Resource Type	Article

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