Type I Error Inflation of Blinded Sample Size Re-Estimation in Equivalence Testing
نویسندگان
چکیده
منابع مشابه
Sample Size Estimation for (Bio)equivalence Testing Between Two Treatments
Standard 2X2 and replicated 2X2m crossover designs are recommended in the regulatory guidelines to establish bioequivalence of generic drug with off patent brand-name drug. Estimation of sample size, in any clinical trial, targets to optimize the resource usage with assurance of having adequate probability (power) to get significant result. This paper discusses the statistical concept behind sa...
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ژورنال
عنوان ژورنال: Statistics in Biopharmaceutical Research
سال: 2020
ISSN: 1946-6315
DOI: 10.1080/19466315.2020.1845232