Donald J. Schuirmann

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Publications

Citations

3.2K

H-Index

Active since

1987

Affiliations

United States Food and Drug Administration(Current)

Center for Drug Evaluation and Research

GlaxoSmithKline (United States)

Thomas Jefferson University

Research Triangle Park Foundation

Donald J. Schuirmann is an author at United States Food and Drug Administration specializing in bioequivalence, bioequivalence study design, and bioequivalence assessment.

Publications per year

1987–2018

Publications

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

Pharmacy, Biostatistics, Bioavailability +10

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

Sam Haidar, Fairouz Makhlouf, Donald J. Schuirmann et al. · The AAPS Journal · 2008 · 103 citations · Full text

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +13

Sequential design approaches for bioequivalence studies with crossover designs

Diane Potvin, Charles E. DiLiberti, Walter W. Hauck et al. · Pharmaceutical Statistics · 2007 · 95 citations

Public Health, Biostatistics, Bioequivalence +16

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Wenlei Jiang, Fairouz Makhlouf, Donald J. Schuirmann et al. · The AAPS Journal · 2015 · 63 citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +17

An individual bioequivalence criterion: regulatory considerations

Mei‐Ling Chen, Rabindra Patnaik, Walter W. Hauck et al. · Statistics in Medicine · 2000 · 61 citations

Pharmacy, Pharmacokinetics, Pharmacology +15

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