Most drug development programs require pharmacology expertise. The Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management is a center of excellence for population PK / PD modeling and Monte Carlo simulation through Pharsight Corp.’s academic licensing program and serves as a Pharmacometrics Core for the NIH Pediatric Pharmacology Research Network (PPRU).

We provide expertise in drug bioavailability, metabolism, pharmacokinetic and pharmacodynamic (PK / PD) studies as well as clinical trials methodology. We explore new pediatric therapeutic modalities, including:

  • Molecular approaches to the treatment of diseases
  • Application of new technology to pharmacodynamic studies and novel drug delivery systems
  • Pediatric formulations and validation of biomarkers and surrogate endpoints

Other research interests include the developmental characteristics and genetic polymorphisms of drug metabolizing enzymes and receptors, as well as population pharmacokinetic pharmacodynamic (PK / PD) modeling and trial simulation technology.

Experienced staff members support PK / PD analysis of study data by:

  • Developing assays for drugs and metabolites using HPLC fluorescence and diode array detection
  • Performing LC tandem mass spectrometry analyses 
  • Serving as centralized resource for multicenter pharmacokinetic studies and concentration-controlled trials
  • Providing population pharmacokinetic analysis and pharmacokinetic / pharmacodynamic modeling and simulation
  • Complying with GLP

Credentials and Certifications

CAP and CLIA accredited