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Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.
Herndon, Thomas M; Ausin, Cristina; Brahme, Nina N; Schrieber, Sarah J; Luo, Michelle; Andrada, Frances C; Kim, Carol; Sun, Wanjie; Zhou, Lingjie; Grosser, Stella; Yim, Sarah; Ricci, M Stacey.
Afiliação
  • Herndon TM; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Ausin C; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Brahme NN; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Schrieber SJ; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Luo M; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Andrada FC; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Kim C; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Sun W; Division of Biometrics VIII, Office of Biostatistics, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Zhou L; Division of Biometrics VIII, Office of Biostatistics, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Grosser S; Division of Biometrics VIII, Office of Biostatistics, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Yim S; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
  • Ricci MS; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America.
PLoS One ; 18(10): e0292231, 2023.
Article em En | MEDLINE | ID: mdl-37788264
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Anafilaxia Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Systematic_reviews Limite: Humans Idioma: En Revista: PLoS One Assunto da revista: CIENCIA / MEDICINA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Anafilaxia Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Systematic_reviews Limite: Humans Idioma: En Revista: PLoS One Assunto da revista: CIENCIA / MEDICINA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos