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AAPS J ; 22(1): 15, 2019 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-31858313

RESUMO

Bioanalysis in biosimilar biological product development (BPD) plays a critical role in demonstrating pharmacokinetic (PK) similarity across products. The 2018 FDA Bioanalytical Method Validation guidance for industry provides general principles in the development, validation, and conduct of bioanalytical assays. Given that the PK similarity assessment in BPD programs involves two or more non-identical products, there are additional considerations for bioanalytical methods. Here in, we provide our perspectives on the definition of (1) a single bioanalytical method in the context of BPD in supporting a PK similarity study, (2) bioanalytical method comparability during accuracy and precision experiments to determine the potential bias difference prior to assessing other validation parameters, and (3) bioanalytical method validations that support PK similarity assessments.


Assuntos
Produtos Biológicos/metabolismo , Medicamentos Biossimilares/metabolismo , Proteínas Sanguíneas/metabolismo , Desenvolvimento de Medicamentos/métodos , Bioensaio/métodos , Bioensaio/normas , Produtos Biológicos/análise , Medicamentos Biossimilares/análise , Proteínas Sanguíneas/análise , Desenvolvimento de Medicamentos/normas , Humanos , Ligantes , Reprodutibilidade dos Testes
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