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In prior works, this group demonstrated the feasibility of valid adaptive sequential designs for crossover bioequivalence studies. In this paper, we extend the prior work to optimize adaptive sequential designs over a range of geometric mean test/reference ratios (GMRs) of 70-143% within each of two ranges of intra-subject coefficient of variation (10-30% and 30-55%). These designs also introduce a futility decision for stopping the study after the first stage if there is sufficiently low likelihood of meeting bioequivalence criteria if the second stage were completed, as well as an upper limit on total study size. The optimized designs exhibited substantially improved performance characteristics over our previous adaptive sequential designs. Even though the optimized designs avoided undue inflation of type I error and maintained power at ≥ 80%, their average sample sizes were similar to or less than those of conventional single stage designs.
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
January 2008,
Pharmaceutical statistics,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
July 2025,
Statistical methods in medical research,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
January 2012,
Pharmaceutical statistics,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
January 2019,
Pharmaceutical statistics,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
January 2019,
Statistics in biopharmaceutical research,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
May 2014,
The AAPS journal,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
August 2003,
Controlled clinical trials,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
January 2003,
Journal of Zhejiang University. Science,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
September 2011,
Journal of biopharmaceutical statistics,
Jialin Xu, and
Charles Audet, and
Charles E DiLiberti, and
Walter W Hauck, and
Timothy H Montague, and
Alan F Parr, and
Diane Potvin, and
Donald J Schuirmann
December 1997,
Journal of pharmacokinetics and biopharmaceutics,
