Enhancing Reproducibility in Bioanalytical Studies

摘要

The FDA's guidance document for bioanalytical methods, "Guidance for Industry, Bioanalytical Method Validation," mandates thorough validation of the bioanalytical methods supporting clinical and non-clinical studies, with a strong emphasis on assay reproducibility to safeguard against analytical bias. This article will discuss method validation while building the case for analytical sensitivity as a prerequisite for highly reproducible validated bioanalytical methods for the quantitative determination of drugs and/or metabolites in biological matrices.