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Clinical pharmacology considerations for the approval of belimumab for the treatment of adult patients with active lupus nephritis: A regulatory perspective.
Liu, Tao; Neuner, Rosemarie; Thompson, Aliza; Pottackal, Ginto; Petullo, David; Liu, Jiang; Nikolov, Nikolay; Sahajwalla, Chandrahas; Doddapaneni, Suresh; Chen, Jianmeng.
Afiliação
  • Liu T; Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Neuner R; Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Thompson A; Division of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drug, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Pottackal G; Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Petullo D; Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Liu J; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Nikolov N; Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Sahajwalla C; Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Doddapaneni S; Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
  • Chen J; Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.
Lupus ; 31(4): 424-432, 2022 Apr.
Article em En | MEDLINE | ID: mdl-35238725
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Farmacologia Clínica / Nefrite Lúpica / Lúpus Eritematoso Sistêmico Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / 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: Farmacologia Clínica / Nefrite Lúpica / Lúpus Eritematoso Sistêmico Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article