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Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies.
Guhl, Mélanie; Mercier, François; Hofmann, Carsten; Sharan, Satish; Donnelly, Mark; Feng, Kairui; Sun, Wanjie; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan; Mentré, France; Comets, Emmanuelle; Bertrand, Julie.
Afiliação
  • Guhl M; Université Paris Cité and Université Sorbonne Paris Nord, Inserm, IAME, 75018, Paris, France. melanie.guhl@inserm.fr.
  • Mercier F; Department of Biostatistics, Roche Innovation Center Basel, Basel, Switzerland.
  • Hofmann C; Department of Clinical Pharmacology, Roche Innovation Center Basel, Basel, Switzerland.
  • 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.
  • Donnelly M; 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.
  • Feng 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, MD, 20993, USA.
  • Sun W; Office of Biostatistics, Office of Translational Sciences, 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.
  • 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.
  • Mentré F; Université Paris Cité and Université Sorbonne Paris Nord, Inserm, IAME, 75018, Paris, France.
  • Comets E; Université Paris Cité and Université Sorbonne Paris Nord, Inserm, IAME, 75018, Paris, France.
  • Bertrand J; Univ Rennes, Inserm, EHESP, Irset - UMR_S 1085, 35000, Rennes, France.
J Pharmacokinet Pharmacodyn ; 49(5): 557-577, 2022 10.
Article em En | MEDLINE | ID: mdl-36112338
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anticorpos Monoclonais Idioma: En Revista: J Pharmacokinet Pharmacodyn Assunto da revista: FARMACOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: França
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anticorpos Monoclonais Idioma: En Revista: J Pharmacokinet Pharmacodyn Assunto da revista: FARMACOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: França