Pharmacy Department

Pharmaceutical Development

About the Pharmaceutical Development Section

The Pharmaceutical Development Section is the component of the NIH Clinical Center Pharmacy Department responsible for managing investigational drugs. PDS staff (pharmacists, chemists, technicians, and pharmacokineticists) help investigators comply with investigational drug management regulations and assist with setting-up studies. PDS has a very limited capability to manufacture non-sterile products; however, PDS can help with identifying a Contract Manufacturing Organization to outsource sterile and non-sterile material production for a clinical trial.

Support for NIH Clinical Center Research

The PDS:

  • manages commercially available and investigational drugs in approximately 1,000 research protocols, including 200 masked studies;
  • oversees the use of all investigational drugs—monitoring drug distribution, accountability, and
  • conducts research on various practical applications of investigational drugs, including compatibility and stability.

Clinical Pharmacokinetics Research Laboratory (CPRL)

The CPRL, the research section in PDS, is dedicated to the study of clinical pharmacokinetics, drug interactions, and pharmacogenetics. The focus areas for research are:

  • Human Immunodeficiency Virus/Hepatitis C Virus Antiviral Pharmacology
  • Phase 1, first-in-human, studies
    • Single/Multiple Ascending Dose
    • Maximum Tolerated dose
    • Dose linearity/proportionality
  • Clinical pharmacology
    • Food-drug interactions
    • Drug-drug interactions
    • Pharmacogenomics
    • Transporter-mediated pharmacokinetic interactions

Contact Parag Kumar, PharmD, Director, CPRL at 301-496-0967 or Parag.kumar@nih.gov to collaborate on a project or for further information.

Related information: Drug Production Outsourcing