A two-stage procedure for bioequivalence studies.
A two-stage experimental procedure for bioequivalence studies is proposed. The procedure is based on the idea that information from a first-stage experiment can be used to form a predictive distribution for the outcome of a second-stage experiment, thus permitting an assessment of the probability of a successful overall outcome. A systematic numerical study of a variety of possible strategies results in the identification of procedures that lead to substantial increases in efficiency compared with single-stage studies.
Racine-Poon
A
A
Mathematical Applications, CIBA-GEIGY AG, Basel, Switzerland.
Grieve
A P
AP
Flühler
H
H
Smith
A F
AF
D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D011336:Probability; D012107:Research Design; D013810:Therapeutic Equivalency