CDS Research

Because of our extensive experience in the private sector and the availability of considerable university resources at MCV/VCU, the CDS specializes in the studies that are more complex and difficult. Our experience includes the types of studies shown below:

• First-Time-in-Man Studies (includes CNS-active drugs, opioid agonists and antagonists).
  
• Rising dose tolerance and safety studies (CDS has complete telemetry capability in two wings, Holter monitoring, 20-lead EEG, automated blood pressure, plysmography, 12-lead ECG).
  
• Single-dose vs. multiple-dose pharmacokinetic (PK), and pharmacodynamic (PD) studies Pharmacodynamic measures include quantitative EEG (two fast-fourier, 20 lead brain mapping units), ECG, impedance cardiography.
  
• Relative and absolute bioavailability (IV vs. oral or other routes, buccal, rectal, subcutaneous) including radioactive and non-radioactive dual-isotope studies.
  
• Bioequivalence studies comparing a marketed dosage form to a new dosage form (IR, Controlled Release Products).
  
• 14C, 3H and 35 S Total Mass Balance studies (studies have included collection and sampling of urine, feces, breath CO2, blood, RBC's, plasma or serum, blister fluid, CSF, and specific tissues (e.g., venereal warts) ? using scintillation counting and/or combustion).
  
• Drug Interaction Studies ? PK and/or PD characterization in normal and special populations.
  
• Regional Intestinal Absorption Studies.? Naso-intestinal intubation, confirmed by fluoroscopy, provides drug delivery to specific sites in the small and large intestine.
  
• Intestinal transit times of drug and dosage forms have been monitored by scintillation cameras using the usual isotopes (Technetium, Indium) and neutron-activated Rare-earth metals (Lanthanide series, including Samarium and Erbium).