Initiating the first study in humans is the first step in generating the required data for a New Drug Application (NDA). QPS's Clinical Services can conduct the following studies to support the application for marketing approval:

 ►Single and Multiple dose safety, tolerability and pharmacokinetic
 ►Drug-drug interaction
 ►Bioequivalence/bioavailability
 ►Effect of food
 ►Pharmacokinetics/Pharmacodynamics
 ►Formulation assessment
 ►Special population (pediatric, elderly, obese)
 ►Gender/race
 ►Radiolabeled mass balance and excretion
 ►Safety pharmacology (QTc interval, GI motility, etc.)
 ►Mechanistic
 ►Enzyme inhibition/induction
 ►CYP profiling

QPS has a 240-bed clinical facility in Springfield, MO dedicated to performing phase 1-phase 3 clinical pharmacology studies. Services for our sponsors include the following:

 ►Protocol development and execution
 ►Experienced clinician investigators and support staff
 ►Dedicated Institutional Review Board
 ►Timely scheduling of studies
 ►Rapid recruitment and completion of study
 ►Data management
 ►QPS can provide the following clinical endpoints: Bioanalysis of the plasma, serum, whole blood, urine samples for systemic exposure, and clearance determinations
 ►Profiling and identification of metabolites
 ►SNP genotyping for patient stratification to effectively screen for the "personalized" medicine approach
 ►Qualitative and/or quantitative protein/biochemical and genomic biomarkers determination for efficacy and PK/PD correlation