Chapter 2 Understanding Bioanalysis Regulations

Bioanalytical data submitted to global health authorities in support of drug approval applications is expected to meet certain regulatory standards and requirements. Bioanalytical assay validation and the conduct of study sample analysis is addressed with a multitude of regulatory guidance documents. This chapter provides an overview of the regulations from a historical perspective to current day developments. Originally written around bioanalysis to support pharmacokinetic studies, bioanalysis regulatory language is now being applied to endogenous biomarker assays and evaluating immunogenicity of large molecule therapeutics. Quality management and documentation are also discussed in this chapter along with the process of how modern bioanalysis regulations are continuing to develop.