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Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events.
Kotarek, Joseph; Stuart, Christine; De Paoli, Silvia H; Simak, Jan; Lin, Tsai-Lien; Gao, Yamei; Ovanesov, Mikhail; Liang, Yideng; Scott, Dorothy; Brown, Janice; Bai, Yun; Metcalfe, Dean D; Marszal, Ewa; Ragheb, Jack A.
  • Kotarek J; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Stuart C; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • De Paoli SH; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Simak J; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Lin TL; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Gao Y; Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Ovanesov M; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Liang Y; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Scott D; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Brown J; Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
  • Bai Y; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892.
  • Metcalfe DD; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892.
  • Marszal E; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993. Electronic address: Ewa.Marszal@fda.hhs.gov.
  • Ragheb JA; Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993. Electronic address: Jack.Ragheb@fda.hhs.gov.
J Pharm Sci ; 105(3): 1023-7, 2016 Mar.
Article en En | MEDLINE | ID: mdl-26886324
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Péptidos / Eritropoyetina / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Material Particulado Tipo de estudio: Risk_factors_studies Límite: Humans Idioma: En Año: 2016 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Péptidos / Eritropoyetina / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Material Particulado Tipo de estudio: Risk_factors_studies Límite: Humans Idioma: En Año: 2016 Tipo del documento: Article