Central Lab Services

Pharmacokinetic Testing

Our bioanalytical scientists work seamlessly with you, from developing assays to reporting data.

For more than 20 years, our scientists have been partnering with clients to develop challenging assays. ABS Laboratories has vast experience in conducting small-molecule and metabolite pharmacokinetic studies—both preclinical and clinical—for submission to regulatory bodies. At ABS, clients have a direct line of communication with the lead scientist involved, who provides a project overview and regular progress updates. Our analysts will follow a sample from receipt through sample preparation and analysis to results—and can assist on data interpretation—assuming full responsibility throughout the process.

Our state-of-the-art systems deliver accuracy and reliability.

We understand the need for high-quality data and the importance of finding new ways to look at clinical research, so we use only LC-MS/MS platforms to quantify and investigate the absorption and excretion of drugs and their metabolites during drug development. Our testing methods range from simple sample dilution to complicated solid-phase extraction and derivatization. We own a large library of validated bioanalytical methods for a multitude of drugs, for rapid initialization and analysis of study samples.

We understand the global regulatory landscape.

Our methods meet EMA and FDA guidelines, and our studies are conducted to GLP and GCP standards. We have a broad understanding of global regulatory processes in all areas of drug development from conducting bioanalysis studies that are ready for regulatory submission for a new drug to supporting the reformulation of existing drugs or medical devices. We are your experienced partner in navigating what can be a complicated landscape.

We offer a depth of integration and partner support.

We develop and validate assays to meet your goals and objectives. The partnership we form with you, coupled with our expertise, accelerates the process. We offer a range of validated methods for pharmaceuticals that are already on the market. We regularly validate assays for multiple analytes to meet regulatory requirements. At ABS, we’ve also developed stabilization procedures for hard-to-assay drugs.