Southern Research has more than 40 years of specialized experience executing comprehensive ADME/PK services in support of drug discovery and development programs. Our diverse client list includes pharmaceutical, biotechnology, government and academic partners. In state-of-the art, GLP-compliant facilities, our highly trained professionals provide clients with critical data required in the preclinical assessment phase in pursuit of IND applications and NDA approvals. In addition, we offer the ability to provide customized study designs to meet our clients' specific needs. These studies may be conducted using radiolabeled or nonradiolabeled test articles.
Southern Research scientists have extensive experience in the design and execution of single and multiple-dose pharmacokinetic studies to analyze multiple parameters, including the examination of dose proportionality, bioavailability, and food effects. In addition, we offer clients the capability of conducting toxicokinetic assessments of systematic exposure in conjunction or simultaneously with ongoing toxicology studies. A range of analytical support is available for these studies including radioassay, LC-MS/MS, HPLC, CE and immunochemistry.
Experienced, qualified pharmacokineticists are available within Southern Research to assist clients with study design, pharmacokinetic modeling, statistical analysis, and data interpretation. These skilled professionals can perform pharmacokinetic (PK), toxicokinetic (TK), or pharmacodynamic (PD) analyses on bioanalytical data generated at Southern Research as well as client-submitted data sets from preclinical and clinical studies. WinNonlin® software is utilized for these analyses.
Compartmental and non-compartmental methods are utilized to examine multiple parameters in defining the pharmacokinetic profiles of compounds. Southern Research utilizes the following standard pharmacokinetic parameters (additional parameters are available upon client request):
Pharmacokinetic Services/Capabilities Include:
ADME Services/Capabilities Include:
For more information about our capabilities, contact us at: