Pharmacometrics

As part of PRC, the Pharmacometrics Study Unit (PSU) headed by Dr. Alan Forrest has been established for over 5 years to conduct translational pharmacology research through interdisciplinary approaches to clinical data analysis. The PSU is comprised of a team of clinical scientists specializing in the fields of Data Management, Pharmacokinetics, Pharmacodynamics, and Biostatistics who provide comprehensive pharmacometric support from protocol development to final integrated study reports.

The Pharmacometrics Study Unit integrates the main components of the pharmacokinetic and pharmacodynamic (PK/PD) modeling process into the laboratory and clinical programs of investigators to enable the research to focus more deeply into complex systems, such as those involving antiretroviral drug interactions, immunosuppressant in transplant patients, development of novel migraine treatment, antibacterial combinations, and cardiovascular treatment optimization.

The Pharmacometrics Study Unit is committed to the following goals for achieving PRC mission success.

1. Development of PK/PD models to optimize clinical data interpretation and facilitate pharmacotherapy individualization.
2. Development of pre-clinical models for PK/PD model building.
3. Design and conduct clinical trials that generate data to implement PK/PD modeling.
4. Collaboration on clinical trials to examine pharmacotherapy regimens and outcomes by applying pharmacometric analyses.
5. Collaboration with faculty members in the development of grant applications, data analysis and PK/PD modeling to optimize treatment outcomes.

The Pharmacometrics Study Unit assists investigators in the conduct of the scientific methodology, which includes derivation of mathematical/statistical models, experimental design, gathering and management of data, fitting of models to data, and simulation of data from mathematical models. Concepts and tools from the disciplines of statistics, engineering science and computer science are used to accomplish these goals. Most projects require the use of standard mathematical/statistical tools, which are accessed via multiple state-of-art packages for PK/PD modeling and statistics. This unit also develops novel mathematical/biostatistical concepts and methodologies to solve complex problems from clinical research.

Research collaborations of the Pharmacometrics Unit have a significant educational component. The faculty members provide educational support to PRC investigators through one-on-one tutorials, seminars, workshops, and formal classes. The educational activities also include a post-doctoral fellowship programs in drug development recently developed with pharmaceutical industry.

The strengths of the Pharmacometrics Unit are summarized as following.

1. Experience and scientific expertise: a team of experts provide high quality clinical support.
2. Multi-disciplinary nature: Collaborative projects encompass HIV/AIDS medicine, antimicrobials, cardiovascular medicine, neuroscience, and transplantation. Clinical pharmacology, bioanalysis and pharmacometrics
3. Innovative database management: The designated IT force and special data management system leverages analysis capabilities.
4. First-rate facilities and equipment: There are over 20 desktop and laptop computers available for pharmacometric analysis. Large computational resources from UB are also accessible. Multiple latest versions of software for PK/PD modeling and statistics have been purchased and installed in these computers. A brief list of these softwares is as following.
   • PK/PD modeling softwares: NONMEM (GloboMax LLC, Hanover , MD ), ADAPT II, WinNonlin (Pharsight, Palo Alto , CA ), WinNonMix (Pharsight, Palo Alto , CA )
   • Statistical softwares: SAS (SAS Institute, Cary , NC ), SYSTAT (SPSS, Chicago , IL ), MINITAB 14 (Minitab Inc., State College , PA )
5. Proven quality assurance: The pharmacometric research is in accordance with 21 CFR part 11, FDA and ICH6 guidelines.