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A Novel Pharmacokinetic Bridging Strategy to Support a Change in the Route of Administration for Biologics.
Ji, Ping; Nikolov, Nikolay; Seymour, Sally; Glaser, Rachel; Ren, Yupeng; Li, Liang; Marathe, Anshu; Ren, Yunzhao; Chen, Jianmeng; He, Lei; Pisal, Dipak; Yapa, Shalini Wickramaratne Senarath; Wang, Yaning; Sahajwalla, Chandrahas.
Afiliación
  • Ji P; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Nikolov N; Division of Pulmonary, Allergy, and Rheumatology Products, Office of Drug Evaluation II, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Seymour S; Division of Pulmonary, Allergy, and Rheumatology Products, Office of Drug Evaluation II, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Glaser R; Division of Pulmonary, Allergy, and Rheumatology Products, Office of Drug Evaluation II, Office of New Drug, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Ren Y; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Li L; Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Marathe A; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Ren Y; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Chen J; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • He L; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Pisal D; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Yapa SWS; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Wang Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993.
  • Sahajwalla C; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993. Electronic address: Chandrahas.Sahajwalla@fda.hhs.gov.
J Pharm Sci ; 108(7): 2490-2499, 2019 07.
Article en En | MEDLINE | ID: mdl-30871994

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos