Bioanalytical Sciences

Southern Research provides bionanalytical research services for the comprehensive evaluation of drug candidates supporting both preclinical GLP and non-GLP studies. Bioanalytical research services are conducted in more than 10,000 square feet of custom-designed, dedicated pharmacy and laboratory space. These facilities house state-of-the-art instrumentation and automation, including LC/MS, LC/MS/MS, GC, GC/MS, and qPCR analytical platforms.

The extensive scientific expertise and industry experience of the Southern Research staff is applied to conducting method development/validation and bioanalysis of biological samples in addition to analytical analysis of dose formulations generated internally or from external laboratories. These samples can be derived from a wide range of preclinical activities, including but not limited to the following: ADME studies, PK/PD and toxicology evaluations, metabolic evaluations, biodistribution, and stability studies. We also support all types of clinical studies from ascending single- and multiple-dose studies to multi-site and bioequivalence.

Bioanalytical research services and capabilities include:

• Homogeneity testing
• Solubility and stability testing
• Bioanalytical method development and validation
• Plasma and tissue drug level determinations (PK/TK, bioavailability, and biodistribution)
• In vitro metabolism studies (analytical)
• Quantitative PCR

Publications