Two-stage Sequential Design

Two-Stage Sequential Design is a statistical inference framework in bioequivalence assessment that belongs to the class of adaptive clinical trial designs and is distinguished by its structured, pre-specified two-phase approach wherein the first stage estimates key parameters to inform the sample size and decision rules of a subsequent confirmatory stage, thereby optimizing trial efficiency and regulatory decision-making for Highly Variable Drug Products.

489

Publications

31.8K

Citations

2K

Authors

839

Institutions

Publications per year

2017–2026

101

Authors

2K

  1. JW
    John Whitehead

    University of Reading, United Kingdom

    12 publications · 1.6K citations

    12

    h-index

  2. MK
    Meinhard Kieser

    Heidelberg University, Germany

    12 publications · 511 citations

    11

    h-index

  3. GS
    Guogen Shan

    University of Nevada, Las Vegas, United States

    8 publications · 142 citations

    8

    h-index

  4. NS
    Nigel Stallard

    University of Warwick, United Kingdom

    6 publications · 388 citations

    6

    h-index

  5. PB
    Péter Bauer

    Statistics Austria, Austria

    6 publications · 666 citations

    6

    h-index

1–5 of 2K

Venues

  1. Statistics in Medicine

    65 publications · 3.4K citations

    29

    h-index

  2. Journal of Clinical Oncology

    30 publications · 2.3K citations

    19

    h-index

  3. Biometrics

    29 publications · 2K citations

    19

    h-index

  4. Biometrical Journal

    16 publications · 471 citations

    14

    h-index

  5. Journal of Biopharmaceutical Statistics

    JBS · 21 publications · 459 citations

    14

    h-index

1–5