Laboratory Testing Blog

Good Laboratory Practice is defined in the OECD Guidelines as “a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”  The purpose of Good Laboratory Practices is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving.

The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been shown to have important physiological effects that may reduce the risk of cardiovascular disease.

The measurement of drugs in biological matrices, such as serum, plasma, blood, urine, and saliva is an important aspect of pharmaceutical product development.  The data obtained in these clinical studies may be required to support regulatory applications for new drug products and generics as well as variations to previously approved drug products.  The results of animal toxicokinetic studies and human clinical trials, including bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a drug substance or drug product. It is critical that the bioanalytical methods used are well established, fully validated and documented that will demonstrate reliable and reproducible results.