Concepedia

Bioequivalence Study Design

Bioequivalence Study Design is the pre-specified methodological framework for a clinical pharmacokinetic study that compares the rate and extent of systemic exposure to an active ingredient from a test and a reference medicinal product, defining the experimental structure, study conditions, and statistical procedures required to determine compliance with regulatory bioequivalence criteria.

945

Publications

34.2K

Citations

3.7K

Authors

1.1K

Institutions

Publications per year

2017–2026

137

Variants

Crossover Study DesignCrossover Study DesignsStudy Design For BioequivalenceStudy Design In Bioequivalence

Parents

Children

Publications

945

A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

Donald J. Schuirmann · Journal of Pharmacokinetics and Biopharmaceutics · 1987 · 2.6K citations · Full text

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Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Journal of Pharmaceutical Sciences · 1992 · 1.1K citations

, , +14

Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

Vinod P. Shah, K.K. Midha, S Dighe et al. · European Journal of Drug Metabolism and Pharmacokinetics · 1991 · 617 citations

, , +14

Design and Analysis of Bioavailability and Bioequivalence Studies

Eric R. Ziegel, Shein Chung Chow, Jiewen Liu · Technometrics · 1994 · 492 citations

, , +12

Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Pharmaceutical Research · 1992 · 446 citations

, , +14

1–5 of 945

Authors

3.7K

  1. LE
    László Endrényi

    University of Toronto, Canada

    26 publications · 813 citations

    18

    h-index

  2. SC
    Shein‐Chung Chow

    Duke University, United States

    24 publications · 949 citations

    16

    h-index

  3. JL
    Jen‐pei Liu

    National Health Research Institutes, Taiwan

    14 publications · 448 citations

    13

    h-index

  4. LT
    László Tóthfalusi

    Semmelweis University, Hungary

    16 publications · 475 citations

    13

    h-index

  5. WW
    Walter W. Hauck

    Thomas Jefferson University, United States

    13 publications · 1K citations

    13

    h-index

1–5 of 3.7K

Institutions

1.1K

  1. Center for Drug Evaluation and Research

    Silver Spring, United States

    26 h-index

    162 publications

    15K citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    20 h-index

    130 publications

    8.5K citations

  3. University of Toronto

    Toronto, Canada

    20 h-index

    38 publications

    1.1K citations

  4. Bristol-Myers Squibb (United States)

    New York, United States

    18 h-index

    55 publications

    2.9K citations

  5. Novartis (Switzerland)

    Basel, Switzerland

    17 h-index

    56 publications

    1.5K citations

  6. Pfizer (United States)

    New York, United States

    13 h-index

    47 publications

    2.2K citations

  7. Zimmer Biomet (Germany)

    Berlin, Germany

    13 h-index

    36 publications

    1.3K citations

  8. National and Kapodistrian University of Athens

    Athens, Greece

    13 h-index

    34 publications

    1.1K citations

1–8 of 1.1K

Venues

  1. Pharmaceutical Research

    42 publications · 2.1K citations

    25

    h-index

  2. PubMed

    Repository · 59 publications · 1.7K citations

    23

    h-index

  3. The Journal of Clinical Pharmacology

    42 publications · 1.3K citations

    22

    h-index

  4. Statistics in Medicine

    35 publications · 1.1K citations

    20

    h-index

  5. 16

    h-index

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