Accurate measurement of drug concentrations in biological matrices (e.g. whole blood, serum, plasma and urine) is essential for research and development of drugs and drug preparations. These data support the efficacy and safety of a drug and are critical to critical decisions based on toxicokinetic, pharmacokinetic, and bioequivalence studies’ results. Therefore, bioanalytical methods applied in the studies should be fully validated and documented in details to yield reliable results.

This Guidelines describes the requirements for the validation of bioanalytical methods, basic requirements for analyzing samples from non-clinical or clinical trials, as well as the requirements for using partial validation or cross validation in place of the full validation of an analytical method. Sections 2 and 3 of the Guidelines mainly focus on chromatographic method, while section 4 focuses on analytical methods for ligand binding assays.

The validation of bioanalytical methods and analysis of test samples should comply with technical requirements specified in this guideline and the analysis on biosamples should follow the principles of Good Laboratory Practice (GLP) or Good Clinical Practice (GCP).