ADVANCES IN DRIED BLOOD SPOT SAMPLING AND BIOANALYTICAL METHOD VALIDATION UNDER ICH M10 GUIDELINES: A COMPREHENSIVE REVIEW

Adaptation of Dried Blood Spot (DBS) as a sample collection technique has gathered significant attention in recent years, which is due to multiple advantages. As this involves a collection of human or animal blood drop and putting them on the specialist paper, this provides multiple benefits like minimal invasive blood sample collection, room temperature or ambient temperature storage till analysis is over. However, all these advantages of DBS do not come easily. Before active application, scientific method development and then method validation as per regulatory requirements is very much required. To ensure achievement of DBS at an optimal level, it is very much essential that the bioanalytical method should be accurate and reproducible. Here International Council for Harmonisation (ICH) M10 guideline plays a pivotal role in supporting a framework for the method validation of methods that will used during regulatory submissions.