Tremblay Guy A, Oldfield Philip R
Immunochemistry, Charles River Preclinical & Clinical Services, 22022 Transcanadienne, Senneville, QC H9X 3R3, Canada.
Bioanalysis. 2009 Jun;1(3):595-609. doi: 10.4155/bio.09.66.
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.
本文总结了用于测定小干扰RNA（siRNA）和寡核苷酸疗法的生物分析方法，重点是杂交方法。文中还考虑了研究性寡核苷酸疗法的化学性质和递送情况。所研究寡核苷酸的性质将决定最佳的分析方法；每种方法都有其优缺点，这取决于寡核苷酸测试品以及预期的毒代动力学和药代动力学研究参数。严格的方法开发和特定的验证标准对于获得高质量结果以支持监管申报至关重要。
