Case Studies

Read the case studies below for specific examples of ways we have helped advance our clients' drug development programs.

Biomarker Analysis by LC/MS/MS

Optimizing enzymatic digestion to create a stable derivative enabled us to develop an LC/MS/MS method to measure concentrations of a key biomarker directly related to the activity of a biologic. This single method provided more sensitivity, increased selectivity, shorter sample preparation and run times, and a more stable analyte compared to the two previous methods initially being used for analysis.
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Simultaneous Determination of Free and Covalently Bound Drug Concentrations

The development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay.
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Development of a Non-Traditional Internal Standard

The development of a non-traditional internal standard by derivatization allowed our client to maintain their rigorous timeline without resorting to an expensive synthetic effort.
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Selective Extraction in Method Development

Employing selective extraction in method development enabled the accurate determination of in vivo drug concentration in plasma samples collected during our client’s Phase I trial.
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Customizing Specimen Collection Kits for Specific Clinical Trial Sampling Requirements

Customizing specimen collection kits for specific clinical trial sampling requirements streamlined our client’s Phase I study and helped ensure that all specimens collected were stabilized, properly labeled, and provided accurate pharmacokinetic data.
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Increasing Assay Sensitivity to Determine Drug Concentration in Unconventional Matrices

Increasing assay sensitivity to determine drug concentration in epithelial lining fluid (ELF) samples allowed our client’s clinical trial to proceed uninterrupted, saving them time and resources.
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