Advances in Dried Blood Spot Sampling and Bioanalytical Method Validation Under Ich M10 Guidelines: a Comprehensive Review
Year: 2025
Type: article
Abstract: 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.
Authors: SUBHRANSHU PANDA, TUSHAR CHAVAN, RAVINDRA BHAVSAR
Institution: Jaipur National University
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4414775489
FWCI:
Cites:
Cited by:
Related to: