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November 18, 2025Journal of Biopharmaceutical Statistics

Blinded sample size re-estimation in a crossover study

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Authors

SZSHAOFEI ZHAOBHBalakrishna HosmaneCCChen Chen

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Implication

Proposed method improves sample size determination and power in bioequivalence studies, indicating adaptive designs may enhance drug development efficiency.

Key Points

  • Novel method achieves accurate blinded sample size re-estimation, enhancing statistical power.
  • Simulation studies demonstrate performance comparable to existing approaches, particularly in complex variance scenarios.
  • Adaptive designs present a promising avenue for drug formulation comparison amidst traditional challenges.
  • Improving sample size determination supports drug development by optimizing study resource allocation.

Cite This Study

ZHAO et al. (2025) studied this question.

synapsesocial.com/papers/6924fef9c0ce034ddc352022https://doi.org/10.1080/10543406.2025.2575947
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  4. 4Paired and AB/BA Cross-Over Design in Early Phase Clinical Trials: A Closer Look at Within-Subject Variance Bias.2026
  5. 5Simple procedures for blinded sample size adjustment that do not affect the type I error rate2003 · 128 citations