title: Bioanalysis of siRNA and oligonucleotide therapeutics in biological fluids and tissues.
abstract: 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.
authors.affiliation: Immunochemistry, Charles River Preclinical & Clinical Services, 22022 Transcanadienne, Senneville, QC H9X 3R3, Canada.
authors.forename: Guy A
authors.initials: GA
authors.lastname: Tremblay
authors.forename: Philip R
authors.initials: PR
authors.lastname: Oldfield
mesh_terms: D000818:Animals; D002851:Chromatography, High Pressure Liquid; D019075:Electrophoresis, Capillary; D006801:Humans; D007118:Immunoassay; D009841:Oligonucleotides / Q000097:blood* / Q000652:urine; D004364:Pharmaceutical Preparations / Q000097:blood* / Q000652:urine; D010599:Pharmacokinetics; D034741:RNA, Small Interfering / Q000097:blood* / Q000652:urine; D021241:Spectrometry, Mass, Electrospray Ionization
chemical_list: D009841:Oligonucleotides; D004364:Pharmaceutical Preparations; D034741:RNA, Small Interfering