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Efficient model-based bioequivalence testing.
Möllenhoff, Kathrin; Loingeville, Florence; Bertrand, Julie; Nguyen, Thu Thuy; Sharan, Satish; Zhao, Liang; Fang, Lanyan; Sun, Guoying; Grosser, Stella; Mentré, France; Dette, Holger.
Afiliação
  • Möllenhoff K; Department of Mathematics, Ruhr-Universität Bochum and Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.
  • Loingeville F; Faculty of Pharmacy, University of Lille, EA 2694: Public health: Epidemiology and Healthcare Quality, 59000 Lille, France.
  • Bertrand J; IAME INSERM, Université de Paris, 75018 Paris, France.
  • Nguyen TT; IAME INSERM, Université de Paris, 75018 Paris, France.
  • Sharan S; Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Zhao L; Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Fang L; Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Sun G; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Grosser S; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Mentré F; IAME INSERM, Université de Paris, 75018 Paris, France.
  • Dette H; Department of Mathematics, Ruhr-Universität Bochum, Germany.
Biostatistics ; 23(1): 314-327, 2022 01 13.
Article em En | MEDLINE | ID: mdl-32696053
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dinâmica não Linear Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dinâmica não Linear Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article