DiFrancesco Robin, Maduke Getrude, Patel Rutva, Taylor Charlene R, Morse Gene D
HIV Clinical Pharmacology Quality Assurance & HIV Clinical Pharmacology Research Programs, University at Buffalo School of Pharmacy & Pharmaceutical Sciences, Translational Pharmacology Research Core, New York State Center of Excellence in Bioinformatics & Life Sciences, 701 Ellicott Street, Buffalo, NY 14203, USA.
Bioanalysis. 2013 Feb;5(3):351-68. doi: 10.4155/bio.12.319.
Research in the many areas of HIV treatment, eradication and prevention has necessitated measurement of antiretroviral (ARV) concentrations in nontraditional specimen types. To determine the knowledgebase of critical details for accurate bioanalysis, a review of the literature was performed and summarized. Bioanalytical assays for 31 ARVs, including metabolites, were identified in 205 publications measuring various tissues and biofluids. 18 and 30% of tissue or biofluid methods, respectively, analyzed more than one specimen type; 35-37% of the tissue or biofluid methods quantitated more than one ARV. 20 and 76% of tissue or biofluid methods, respectively, were used for the analysis of human specimens. HPLC methods with UV detection predominated, but chronologically MS detection began to surpass. 40% of the assays provided complete intra- and inter-assay validation data, but only 9% of publications provided any stability data with even less for the prevalent ARV in treatments.
在人类免疫缺陷病毒(HIV)治疗、根除及预防等诸多领域的研究中,需要对非传统样本类型中的抗逆转录病毒(ARV)浓度进行测定。为了确定准确生物分析关键细节的知识库,我们对文献进行了回顾并总结。在205篇测量各种组织和生物流体的出版物中,鉴定出了针对31种抗逆转录病毒药物(包括代谢物)的生物分析方法。分别有18%和30%的组织或生物流体方法分析了不止一种样本类型;35%-37%的组织或生物流体方法定量了不止一种抗逆转录病毒药物。分别有20%和76%的组织或生物流体方法用于分析人类样本。以紫外检测的高效液相色谱法占主导,但按时间顺序质谱检测开始超过它。40%的分析方法提供了完整的批内和批间验证数据,但只有9%的出版物提供了任何稳定性数据,对于治疗中普遍使用的抗逆转录病毒药物,稳定性数据更少。