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New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling.
Loingeville, Florence; Bertrand, Julie; Nguyen, Thu Thuy; Sharan, Satish; Feng, Kairui; Sun, Wanjie; Han, Jing; Grosser, Stella; Zhao, Liang; Fang, Lanyan; Möllenhoff, Kathrin; Dette, Holger; Mentré, France.
Afiliação
  • Loingeville F; University of Paris, IAME INSERM, UMR 1137, 75018, Paris, France. florence.loingeville@univ-lille.fr.
  • Bertrand J; University of Lille, CHU Lille, ULR 2694 - METRICS : Evaluation of Health Technologies and Medical Practices, F-59000, Lille, France. florence.loingeville@univ-lille.fr.
  • Nguyen TT; Laboratoire de Biomathématiques, Faculté de Pharmacie, 3 Rue du Professeur Laguesse, 59 000, Lille, France. florence.loingeville@univ-lille.fr.
  • Sharan S; University of Paris, IAME INSERM, UMR 1137, 75018, Paris, France.
  • Feng K; University of Paris, IAME INSERM, UMR 1137, 75018, Paris, France.
  • Sun W; 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, Maryland, 20993, USA.
  • Han J; 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, Maryland, 20993, USA.
  • Grosser S; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Zhao L; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Fang L; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Möllenhoff K; 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, Maryland, 20993, USA.
  • Dette H; 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, Maryland, 20993, USA.
  • Mentré F; Department of Mathematics, Ruhr-Universitat Bochum, Bochum, Germany.
AAPS J ; 22(6): 141, 2020 10 30.
Article em En | MEDLINE | ID: mdl-33125589
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Equivalência Terapêutica / Estudos de Equivalência como Asunto / Modelos Biológicos Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
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XML
PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Equivalência Terapêutica / Estudos de Equivalência como Asunto / Modelos Biológicos Idioma: En Ano de publicação: 2020 Tipo de documento: Article