Patel Shefali R, Bryan Peter, Spooner Neil, Timmerman Philip, Wickremsinhe Enaksha
DMPK Department, Discovery Sciences, Janssen Research & Development, LLC, 1400 McKean Road, Springhouse, PA 19477, USA.
B2S Life Sciences, Mendham, NJ 07945, USA.
Bioanalysis. 2019 Apr;11(7):619-628. doi: 10.4155/bio-2019-0019. Epub 2019 Apr 11.
There is continuing interest in the development and application of various microsampling technologies for drug development. The AAPS bioanalytical community microsampling subgroup and the European Bioanalysis Forum conducted a survey of their members (39 individual organizations). This gives a snapshot of current practices and demonstrates that implementation of microsampling approaches is becoming increasingly commonplace, but not universal. Greater adoption was observed for nonclinical studies, particularly nonregulatory. A number of respondents reported that they have included microsampling data in regulatory submissions. Another important observation was that where microsampling is employed for clinical studies, dried blood approaches predominate, reflecting the interest in their use where they enable sample collection which is not feasible with standard approaches or to derive richer data sets.
对于各种用于药物研发的微量采样技术的开发和应用,人们一直保持着兴趣。美国药学科学家协会生物分析社区微量采样小组和欧洲生物分析论坛对其成员(39个独立组织)进行了一项调查。这提供了当前实践的一个快照,并表明微量采样方法的实施正变得越来越普遍,但并非普遍采用。在非临床研究中,尤其是非监管性研究中,采用率更高。一些受访者报告称,他们已将微量采样数据纳入监管申报材料中。另一个重要的观察结果是,在临床研究中采用微量采样时,干血样方法占主导地位,这反映出人们对其在能够实现标准方法无法进行的样本采集或获取更丰富数据集的情况下使用的兴趣。