Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies.

Peck, Carl; Campbell, Gregory; Yoo, Isaac; Feng, Kairui; Hu, Meng; Zhao, Liang

Peck, Carl; Campbell, Gregory; Yoo, Isaac; Feng, Kairui; Hu, Meng; Zhao, Liang.

Afiliação

Peck C; NDA Partners, a ProPharma Group Company, Washington, DC, USA. ccpeck@icloud.com.
Campbell G; Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, San Francisco, CA, USA. ccpeck@icloud.com.
Yoo I; NDA Partners, a ProPharma Group Company, Washington, DC, USA.
Feng K; GCStat Consulting LLC, Silver Spring, AR, USA.
Hu M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, AR, USA.
Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, AR, USA.

AAPS J ; 24(5): 97, 2022 09 01.

Article em En | MEDLINE | ID: mdl-36050426

Assuntos

Equivalência Terapêutica; Área Sob a Curva; Teorema de Bayes; Estudos Cross-Over; Humanos; Tamanho da Amostra

Palavras-chave

ANDA; credible interval; extreme values; geometric mean ratio; two-way crossover study

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Equivalência Terapêutica Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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