Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program.

Mora, Johanna R; White, Joleen T; Chilewski, Shannon D; Qu, Qiang; Stocker, Dennis; Luo, Linlin; Lavelle, Amy

Mora, Johanna R; White, Joleen T; Chilewski, Shannon D; Qu, Qiang; Stocker, Dennis; Luo, Linlin; Lavelle, Amy.

Afiliação

Mora JR; Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.
White JT; Drug Metabolism & Pharmacokinetics, EMD Serono, Billerica, MA, USA.
Chilewski SD; Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.
Qu Q; Drug Metabolism & Pharmacokinetics, EMD Serono, Billerica, MA, USA.
Stocker D; Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.
Luo L; Formerly at Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA; Currently at Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck, Kenilworth, NJ, USA.
Lavelle A; Immunochemistry Department, PPD Laboratories, Richmond, VA, USA.

Bioanalysis ; 12(7): 431-443, 2020 Apr.

Article em En | MEDLINE | ID: mdl-32343147

Assuntos

Alergia e Imunologia/normas; Projetos de Pesquisa/tendências; Humanos

Palavras-chave

immunogenicity; life-cycle management; limits of comparability; method comparison; method transfer; pooled immunogenicity

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Alergia e Imunologia Limite: Humans Idioma: En Revista: Bioanalysis Ano de publicação: 2020 Tipo de documento: Article

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