A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment.

Li, Zhe; Du, Xiulian; Wang, Yow-Ming C

Li, Zhe; Du, Xiulian; Wang, Yow-Ming C.

Afiliación

Li Z; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver Spring, MD, USA. Zhe.Li@fda.hhs.gov.
Du X; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver Spring, MD, USA.
Wang YC; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver Spring, MD, USA.

Pharm Res ; 41(1): 13-27, 2024 Jan.

Article en En | MEDLINE | ID: mdl-37910341

Asunto(s)

Anticuerpos Monoclonales; Estados Unidos; Estudios Retrospectivos; Predicción; United States Food and Drug Administration

Palabras clave

clinical pharmacokinetic study; comparability; fc fusion protein; manufacturing change; monoclonal antibody

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticuerpos Monoclonales País/Región como asunto: America do norte Idioma: En Revista: Pharm Res Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

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