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PHARMACOKINETICS, PHARMACODYNAMICS & DRUG METABOLISM

NANCY C. SAMBOL, PHARM. D., Associate Professor Biopharmaceutical Sciences & Clinical Pharmacy.

The primary goal of Dr. Sambol’s research group is to advance methods of new drug development as they relate to pharmacokinetics (PK) and pharmacodynamics (PD), particularly population approaches (those that consider patient traits and variability). Pharmaceutical companies and other investigators provide real-life issues and challenges on which their work is based. Ongoing and future investigations include the following issues: 1) population PK/PD study design and analysis when data are censored (e.g., analgesic trials and bronchoprovocation studies); 2) population PK/PD study design and analysis for investigating genetic variables, particularly with respect to cancer chemotherapeutic agents; and 3) utilization of population PK models for individualizing cancer chemotherapy administration. Secondarily, they strive to gain specific knowledge about drugs that contribute to their improved clinical usage. For example, we are developing a PK and PK/PD profile of human B-type natriuretic peptide. They use a variety of PK/PD and statistical software including NONMEM, S-Plus and Win Nonlin.

SELECTED PUBLICATIONS:

  1. Liu CY, Sambol NC. Nonlinear mixed effects models of analgesic trial data. J Biopharm Stat, 9(2):253-270, 1999.
  2. Sambol NC, Liu CY, Williams P, Baker J. Population method is critical to dose-response assessment of a bronchodilator studied with a bronchoprovocation design. In European Cooperation in the Field of Scientific and Technical Research: The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose, pp. 337-341. Edited by Aarons L, Balant LP, Danhof M, Gex-Fabry M, Gundert-Remy UA, Karlsson MO, Mentre F, Morselli PL, Rombout F, Rowland M, Steimer LL and Vozeh S. Brussels, Luxembourg, 1997.
  3. Sambol NC, Chiang J, O'Conner M, Liu CY, Lin ET, Goodman AM, Benet LZ, Karam JH. Pharmacokinetics and pharmacodynamics of metformin in healthy subjects and patients with noninsulin-dependent diabetes mellitus. J Clin Pharmacol, 36(11):1012-1021, 1996.

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