LC-MS/MS Bioanalysis Method Development, Validation, and Sample Analysis: Points to Consider When Conducting Nonclinical and Clinical Studies in Accordance with Current Regulatory Guidances

Recently, there has been a heightened public awareness of drug safety across the globe. Nonclinical and clinical pharmacokinetic and toxicokinetic toxicology safety studies all require that the study samples be analyzed under the auspices of good laboratory practice (GLP) standards. GLPs are followed in order to ensure that safety studies are reliable and accurate. Several countries have issued or are in the process of issuing their own versions of bioanalytical guidance documents for performing method validation activities; however, each one is slightly different. These differences often make complying with regulatory requirements difficult and cumbersome. Several networking organizations have been working diligently to harmonize the various global bioanalytical guidance documents. This paper attempts to shed light on some of the critical points to consider when performing bioanalytical method development and GLP compliant validation activities from a scientist’s perspective.