Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events
Joseph A. Kotarek(Center for Biologics Evaluation and Research), Christine Stuart(Center for Biologics Evaluation and Research), Silvia H. De Paoli(United States Food and Drug Administration), Jan Šimák(Center for Biologics Evaluation and Research), Tsai-Lien Lin(Center for Biologics Evaluation and Research), Yamei Gao(United States Food and Drug Administration), Mikhail V. Ovanesov(United States Food and Drug Administration), Yideng Liang(United States Food and Drug Administration), Dorothy E. Scott(United States Food and Drug Administration), Janice Brown(United States Food and Drug Administration), Yun Bai(National Institutes of Health), Dean D. Metcalfe(National Institute of Allergy and Infectious Diseases), Ewa Marszal(Center for Biologics Evaluation and Research), Jack A. Ragheb(Center for Drug Evaluation and Research)
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