The Clinical Pharmacology Unit (CPU) in the Department of Pharmacy Practice and Science is a multi-disciplinary clinical research resource for UMB investigators, contract research organizations (CROs) and pharmaceutical industry. The CPU designs and conducts Clinical Pharmacology trials focusing on PK/PD, drug metabolism, renal function evaluation, and drug-drug interactions. Data obtained from clinical trials (Phase I-IV) are analyzed using NONMEM, WinNonlin, and SAS.

The CPU also provides consultation for regulatory submissions, provides scientific input for clinical protocols, clinical development plans, investigator brochures, and clinical pharmacology sections of IND and NDA submissions. The CPU independently develops clinical pharmacology analysis plans, evaluates clinical trial data using advanced exploratory data analyses techniques, performs clinical trial simulations and applies novel pharmacometric principles to clinical trial data.