期刊
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
卷 28, 期 2, 页码 155-169出版社
KLUWER ACADEMIC/PLENUM PUBL
DOI: 10.1023/A:1011503032353
关键词
crossover design; parallel design; normal distribution; lognormal distribution; log transformation; robust
Sample size calculation plays an important role in bioequivalence trials. In practice, a bioequivalence study is usually conducted under a crossover design or a parallel design with raw data or log-transformed data. In this paper, we discuss the differences in sample size calculation between a crossover design and a parallel design with raw data ol log-transformed data. Formulas for sample size calculation under a crossover design and a parallel design with raw data or log-transformed data are derived. A brief discussion for the relationship among these formulas is given.
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