Internal Standards (IS) monitoring in CROs: Anvisa perspective

Lima Santos Gustavo Mendes; Freitas Fernandes Eduardo Agostinho

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Internal Standards (IS) monitoring in CROs: Anvisa perspective

机译：内部标准（IS）监测在CROS中：ANVISA透视

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来源
《Bioanalysis》 |2019年第18期|共3页
作者
Lima Santos Gustavo Mendes; Freitas Fernandes Eduardo Agostinho;
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作者单位

Agencia Nacl Vigilancia Sanitaria Anvisa SIA Gen Off Med Trecho 5 Area Especial 57 BR-71205050;

Agencia Nacl Vigilancia Sanitaria Anvisa SIA Coordinat Therapeut Equivalence Trecho 5 Area;

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原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词
Anvisa; bioanalysis; bioequivalence; biotherapeutics; internal standards; regulatory;

机译：anvisa;生物分析;生物等效;生物治疗;内部标准;监管;

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1. Internal Standards (IS) monitoring in CROs: Anvisa perspective [J] . Lima Santos Gustavo Mendes, Freitas Fernandes Eduardo Agostinho Bioanalysis . 2019,第18期

机译：内部标准（IS）监测在CROS中：ANVISA透视
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3. Isotopic analogs as internal standards for quantitative analyses by GC/MS--evaluation of cross-contribution to ions designated for the analyte and the isotopic internal standard. [J] . Chang WT, Lin DL, Liu RH Forensic science international . 2001,第3期

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4. Large-scale Targeted Analysis of Post-Translational Modifications by Internal Standard-Triggered Parallel Reaction Monitoring: Application to Determination of Phosphorylation Site Occupancy [C] . Bruno Domon, Sara Rosati, Adele Bourmaud, ASMS Conference on Mass Spectrometry and Allied Topics . 2016

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5. Mechanistic study of alternating current iontophoresis and evaluation of internal standard in iontophoretic monitoring. [D] . Yan, Guang. 2004

机译：交流电离子电渗的机理研究和内标的评价。
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7. Development and validation of a multiplex UHPLC-MS/MS assay with stable isotopic internal standards for the monitoring of the plasma concentrations of the antiretroviral drugs bictegravir, cabotegravir, doravirine, and rilpivirine in people living with HI [O] . Perrine Courlet, Susana Alves Saldanha, Matthias Cavassini, 2020

机译：多重UHPLC-MS / MS测定的开发和验证具有稳定的同位素内部标准，用于监测抗逆转录虫药物Bictegravir，Cabotegravir，Doravirine和Hi的人们的血脂毒素和瑞培的血浆浓度

Internal Standards (IS) monitoring in CROs: Anvisa perspective

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