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Statistical Considerations in Assessing Bioequivalence with Baselines: A Case Study of Endogenous Drugs

Sang-Gue Park, Sangyoung Kim

J Health Info Stat. 2018;43(2):134-139. Published online 2018 May 31 DOI: https://doi.org/10.21032/jhis.2018.43.2.134

Statistical Considerations in Assessing Bioequivalence with Baselines: A Case Study of Endogenous Drugs

Sang-Gue Park, Sangyoung Kim

Journal of Health Informatics and Statistics. 2018;43(2):134-139

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Assessing the bioequivalence of analogues of endogenous substances (‘endogenous drugs’): considerations to optimize study design

Sanjeeva Dissanayake

British Journal of Clinical Pharmacology. 2010;69(3):238-244

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Clinical Considerations of Bioequivalence for Topical Dermatologic Drugs

Jessica Schweitzer, Howard I. Maibach

Topical Drug Bioavailability, Bioequivalence, and Penetration. 2014;371-377

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Assessing product bioequivalence for extended-release formulations and drugs with long half-lives

R. GEHRING, M. MARTINEZ

Journal of Veterinary Pharmacology and Therapeutics. 2012;35:3-9

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Assessing bioequivalence of generic antiepilepsy drugs by indirect comparisons

Alfredo García Arieta

Annals of Neurology. 2012;71(5):724-725

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UPLC-MS/MS method for bioequivalence study of oral drugs of meldonium

Yuriy V. Pidpruzhnykov, Valerii E. Sabko, Volodymyr V. Iurchenko, Igor A. Zupanets

Biomedical Chromatography. 2011;26(5):599-605

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Some statistical considerations on the FDA draft guidance for individual bioequivalence

Francis C. Hsuan

Statistics in Medicine. 2000;19(20):2879-2884

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BIOEQUIVALENCE STUDIES OF TOPICAL PREPARATIONS: STATISTICAL CONSIDERATIONS

WALTER W. HAUCK

International Journal of Dermatology. 1992;31(s1):29-33

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Assessing bioequivalence of generic antiepilepsy drugs

Gregory L. Krauss, Brian Caffo, Yi-Ting Chang, Craig W. Hendrix, Kelly Chuang

Annals of Neurology. 2011;70(2):221-228

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Limitations of the MANOVA of statistical moments in bioequivalence trials of drugs with slow elimination rate: A study with spironolactone

A. Concheiro, M. Llabres, R. Martinez, J. L. Vila

Biopharmaceutics & Drug Disposition. 1986;7(3):253-264

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