Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk.

Wickramarachchi, Dilki; Steeno, Gregory; You, Zhiping; Shaik, Saleem; Lepsy, Christopher; Xue, Li

Wickramarachchi, Dilki; Steeno, Gregory; You, Zhiping; Shaik, Saleem; Lepsy, Christopher; Xue, Li.

Afiliação

Wickramarachchi D; Immunogenicity Sciences, Biomedicine Design, Worldwide Research, Development & Medical, Pfizer Inc., Andover, Massachusetts, USA.
Steeno G; Nonclinical Biostatistics, Early Clinical Development, Worldwide Research, Development & Medical, Pfizer Inc., Groton, Connecticut, USA.
You Z; Nonclinical Biostatistics, Early Clinical Development, Worldwide Research, Development & Medical, Pfizer Inc., Groton, Connecticut, USA.
Shaik S; Immunogenicity Sciences, Biomedicine Design, Worldwide Research, Development & Medical, Pfizer Inc., Andover, Massachusetts, USA.
Lepsy C; Immunogenicity Sciences, Biomedicine Design, Worldwide Research, Development & Medical, Pfizer Inc., Andover, Massachusetts, USA.
Xue L; Immunogenicity Sciences, Biomedicine Design, Worldwide Research, Development & Medical, Pfizer Inc., Andover, Massachusetts, USA. xueli08@yahoo.com.

AAPS J ; 22(5): 114, 2020 08 24.

Article em En | MEDLINE | ID: mdl-32839919

Assuntos

Produtos Biológicos/efeitos adversos; Células Dendríticas/efeitos dos fármacos; Avaliação de Medicamentos/métodos; Imunogenética/métodos; Humanos; Medição de Risco/métodos

Palavras-chave

DC activation assay; acceptance and reporting criteria; fit-for-purpose validation; immunogenicity; screening and risk assessment

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Texto completo: 1 Temas: ECOS / Aspectos_gerais Bases de dados: MEDLINE Assunto principal: Produtos Biológicos / Células Dendríticas / Avaliação de Medicamentos / Imunogenética Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Limite: Humans Idioma: En Revista: AAPS J Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos

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