Bioanalysis of siRNA and oligonucleotide therapeutics in biological fluids and tissues

被引：38

作者：

Tremblay, Guy A. ^{[1
]}

Oldfield, Philip R. ^{[1
]}

机构：

[1] Charles River Preclin & Clin Serv, Senneville, PQ H9X 3R3, Canada

来源：

BIOANALYSIS | 2009年 / 1卷 / 03期

关键词：

PERFORMANCE LIQUID-CHROMATOGRAPHY; ELECTROSPRAY MASS-SPECTROMETRY; SHORT INTERFERING RNA; NUCLEIC-ACID; PHOSPHOROTHIOATE OLIGONUCLEOTIDE; ANTISENSE OLIGONUCLEOTIDE; IN-VITRO; CAPILLARY-ELECTROPHORESIS; HYBRIDIZATION ASSAY; METHOD VALIDATION;

D O I：

10.4155/BIO.09.66

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

This article summarizes bioanalytical avenues for the determination of siRNA and oligonucleotide therapeutics, with an emphasis on hybridization methods. Aspects of the chemistry and delivery of investigational oligonucleotide therapeutics are considered. The nature of the oligonucleotide under investigation will dictate the best analytical course of action; each method has its advantages and disadvantages, depending upon the oligonucleotide test article and the anticipated toxicokinetic and pharmacokinetic study parameters. Stringent method development and specific validation criteria are essential to attain the best quality results in support of a regulatory filing.

引用

页码：595 / 609

页数：15

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