Best Practices in LC‐MS Method Development and Validation for Dried Blood Spots

Dried blood spot (DBS) sampling has been being explored as an important microsampling tool in drug research and development and post-approval therapeutic drug monitoring (TDM) due to its many undeniable advantages and benefits. This chapter provides an overview on the best practices in LC-MS method development and validation for quantitative analysis of dried blood spot (DBS) samples. In order to develop a robust DBS LC-MS assay method, some DBS sample unique technical challenges, such as spot homogeneity, hematocrit effect, use of internal standards and extraction recovery, etc. must be properly evaluated and any identified issues must be addressed. The chapter discusses in detail of the current approaches to addressing those possible issues.