Bioanalytical Core

The Bioanalytical Core laboratory is a part of the Center for Clinical Pharmacology, and it provides quantitative bioanalytical services (i.e., the analysis of small molecule drugs, metabolites and biomarkers in blood, serum, plasma, urine, ultrafiltrate, micro-dialysate, dried blood spot, and tissue homogenates) used for drug discovery and development.

The Bioanalytical Core supports the Center for Clinical Pharmacology’s efforts by developing and validating robust ultra-performance liquid chromatography/tandem mass spectrometry methods to analyze natural products, drugs, and metabolites in various biological samples. In addition, the laboratory is evaluating novel microsampling approaches to facilitate pediatric clinical trials.

Available services include:

• Assay development and rapid sample analysis for preclinical studies
• Assay development, validation, and sample analysis for clinical studies
• Plasma protein binding of small molecule drugs and metabolites
• Stability studies for drugs in various formulations
• Pre-study design and label preparation for clinical studies using Watson LIMS

Validated assays include:

• Dexmedetomidine
• Cefazolin
• Cefepime
• Fluconazole
• Amicar
• Midazolam and 1 and 4-hydroxymidazolam metabolites
• Morphine, morphine-3-glucuronide and morphine-6-glucuronide
• Ketamine and Norketamine
• Milrinone
• Actinomycin D
• Vincristine
• Alisertib (MLN8237)
• Efavirenz
• Aprepitant (EMEND IV)
• Tenofovir