Londhe Vaishali, Rajadhyaksha Madhura
SPPSPTM, SVKM's Narsee Monjee Institute of Management Studies, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India.
SPPSPTM, SVKM's Narsee Monjee Institute of Management Studies, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India; Sitec Labs. Ltd. PEE-DEE Infotech, Plot no. Gen-40, TTC, MIDC Behind Millennium Business Park, Near Nelco, Mahape, New Mumbai 400710, India.
J Pharm Biomed Anal. 2020 Apr 15;182:113102. doi: 10.1016/j.jpba.2020.113102. Epub 2020 Jan 25.
Microsampling, a reduced volume (< 50 μl) sampling method has successfully gained attention at the International Conference on Harmonization (ICH) level. It has been reflected in a few guidelines like ICH SA3, S11 and M10. The established benefits of microsampling support its use in Toxicokinetic (TK) and Pharmacokinetic (PK) studies, clinical studies, neonate sampling and remote sampling. When designing the TK component of a juvenile animal study, microsampling and sparse sampling (if justified) are strongly encouraged from the view of 3Rs (Replace, Refine, and Reduce). The novel sampling techniques arose with benefits over conventional sampling in terms of ease of sampling, storage, and shipment. These improved sampling techniques are less invasive and preferred by patients and trial participants. For the acceptance of these techniques in regulated bioanalysis, it is essential to prove its suitability with a robust and reliable method. Though there are many opportunities for the newer and smarter microsampling devices, the major obstacles are hematocrit influence, homogeneity of samples, repeats, incurred samples reanalysis and regulatory acceptance. With the advancement in techniques, opportunities are marching ahead of obstacles. The two microsampling techniques Dried Blood Spot (DBS) and Volumetric Absorption Microsampling (VAMS) are studied and elaborated in this article with respect to bioanalytical consideration, method validation and regulatory perspectives on its acceptance in regulated bioanalysis.
微量采样是一种采血量减少（<50 μl）的采样方法，已在国际人用药品注册技术协调会（ICH）层面成功获得关注。这已反映在一些指南中，如ICH SA3、S11和M10。微量采样已确立的优势支持其在毒代动力学（TK）和药代动力学（PK）研究、临床研究、新生儿采样及远程采样中的应用。在设计幼年动物研究的TK部分时，从3R原则（替代、优化和减少）的角度出发，强烈鼓励采用微量采样和稀疏采样（如合理）。新型采样技术在采样、储存和运输的便捷性方面比传统采样更具优势。这些改进的采样技术侵入性较小，更受患者和试验参与者青睐。为使这些技术在规范的生物分析中被接受，必须用一种稳健且可靠的方法证明其适用性。尽管更新、更智能的微量采样设备有很多机会，但主要障碍包括血细胞比容影响、样品均匀性、重复性、已测定样品的重新分析以及监管部门的接受度。随着技术的进步，机遇正超越障碍。本文针对干血斑（DBS）和体积吸收微量采样（VAMS）这两种微量采样技术，从生物分析考量、方法验证以及其在规范生物分析中被接受的监管角度进行了研究和阐述。
