Lessons learned from regulatory submissions involving endogenous therapeutic analyte bioanalysis.

Yu, Chongwoo; Jiang, Wenlei; Matta, Murali; Wang, Rong; Haidar, Sam; Seo, Hyeonglim

Yu, Chongwoo; Jiang, Wenlei; Matta, Murali; Wang, Rong; Haidar, Sam; Seo, Hyeonglim.

Afiliação

Yu C; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US FDA), Silver Spring, MD 20993, USA.
Jiang W; Office of Research & Standards (ORS), Office of Generic Drugs (OGD), CDER, US FDA, Silver Spring, MD 20993, USA.
Matta M; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US FDA), Silver Spring, MD 20993, USA.
Wang R; Office of Bioequivalence (OB), OGD, CDER, US FDA, Silver Spring, MD 20993, USA.
Haidar S; Office of Study Integrity & Surveillance (OSIS), OTS, CDER, US FDA, Silver Spring, MD 20993, USA.
Seo H; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation & Research (CDER), US FDA), Silver Spring, MD 20993, USA.

Bioanalysis ; 16(3): 171-184, 2024 Feb.

Article em En | MEDLINE | ID: mdl-38088828

Assuntos

Desenvolvimento de Medicamentos; Espectrometria de Massas em Tandem; Cromatografia Líquida; Ácidos Graxos

Palavras-chave

background subtraction; bioanalytical method validation; calibration standards; endogenous therapeutic analytes; matrix effect; quality controls; sample preparation; standard addition; surrogate analyte; surrogate matrix

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Espectrometria de Massas em Tandem / Desenvolvimento de Medicamentos Idioma: En Revista: Bioanalysis Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos

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