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Design and inference for 3‐stage bioequivalence testing with serial sampling data

Design and inference for 3‐stage bioequivalence testing with serial sampling data

A bioequivalence test is to compare bioavailability parameters, such as the maximum observed concentration (Cmax ) or the area under the concentration-time curve, for a test drug and a reference drug. During the planning of a bioequivalence test, it requires an assumption about the variance of Cmax or area under …