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, 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.

Afiliação

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 em En | MEDLINE | ID: mdl-26886324

Assuntos

Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia; Eritropoetina/administração & dosagem; Eritropoetina/efeitos adversos; Material Particulado/administração & dosagem; Material Particulado/efeitos adversos; Peptídeos/administração & dosagem; Peptídeos/efeitos adversos; Células Cultivadas; Química Farmacêutica/métodos; Ensaios Clínicos Fase III como Assunto; Hipersensibilidade a Drogas; Humanos; Nanopartículas/administração & dosagem; Nanopartículas/efeitos adversos; Vigilância de Produtos Comercializados

Palavras-chave

formulation; particle sizing; peptides; protein aggregation

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Peptídeos / Eritropoetina / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos / Material Particulado Tipo de estudo: Risk_factors_studies Limite: Humans Idioma: En Revista: J Pharm Sci Ano de publicação: 2016 Tipo de documento: Article

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