Drug Disposition

For more than 40 years, Southern Research has provided pharmaceutical, biotechnology, government (including NIH) and academic partners with high-quality essential services in support of numerous drug discovery and development programs. Our well equipped facilities are ideally suited for the performance of absorption, distribution, metabolism and elimination studies of organic and biological compounds. Metabolic profiling, including the isolation and identification of metabolites, along with pharmacokinetic, analyses and pharmacodynamic evaluations ensure that the full complement of ADME/PK requirements are met. With 6 FDA-approved anti-cancer therapies discovered at Southern Research and another 4 in clinical trials, we are continuously demonstrating our commitment to excellence and the value of partnering with us in the search for tomorrow's breakthrough discoveries. We evaluate numerous new therapies each year, providing critical data that allows our partners to make the key decisions at the earliest opportunity in the pursuit of IND applications and NDA approvals.

Test Species

• Rodents, including cotton rats, nude and transgenic mice, and tumor-bearing mice and rats
• Dogs
• Non-human primates
• Rabbits

Routes of Administration

• Oral gavage / oral capsule
• Dermal
• Parenteral injection (IV, IP, IM, SC)
• Continuous infusion
• Intranasal (IN)
• Rectal
• Surgical implant
• Portal vein infusion

Pharmacokinetics

• Single and multiple dose evaluations varying by species and administration routes
• Absolute bioavailability to determine extent of absorption
• Relative bioavailability for comparison of formulation / administration route
• Dose proportionality and linearity of absorption and disposition kinetics
• Pharmacokinetic species-to-species extrapolations
• Toxicokinetic support for acute, subchronic, chronic and carcinogenicity studies

Absorption, Distribution, Metabolism and Elimination

• Protein binding determinations
• Mass balance
• Rates and routes of elimination
• Single and multiple dose tissue distribution evaluations, including isolation and identification of metabolites in plasma, serum, urine, feces, bile and special tissues (CSF, ocular)
• In vitro metabolic profiling
• Pathway definition and species-to-species comparisons

Pharmacodynamics
Including correlation of drug levels to:

• Target- or organ-specific enzyme activity
• CBC alterations
• Proteomic and genomic changes
• Tumor growth
• Cell permeability
• Modulation of Cell Cycle pathways