Clinical Pharmacology & Experimental Therapeutics Center

Analytical Instrumentation:

The Center鈥檚 analytical laboratory specializes in developing and validating methods for the analysis of both small- and large-molecule pharmaceutical agents, their metabolites, and biomarkers in complex biologic matrices using state-of-the-art bioanalytical techniques.

A Sciex QTRAP庐 6500+ which is interfaced with a UHPLC, nano-LC or micro-LC system.
A Sciex QTRAP庐 5500 which is interfaced with a UHPLC, nano-LC or micro-LC system.

A Sciex TripleTOF鈩� 5600 which is interfaced with interfaced with a UHPLC, nano-LC or micro-LC system.

The Center鈥檚 UHPLC-MS/MS systems can be interfaced with Sciex鈥檚 SelexION鈩� which provides the unique capability to separate analytes with identical molecular weights and retention times.

Faculty Members:

Professor
Department of Pharmacy Practice
Department of Pharmaceutical Sciences

Focus of Research:
Clinical Pharmacology and Metabolism

Dr. Putnam鈥檚 work in clinical pharmacology and experimental therapeutics over the past 18 years has led to the development, approval and commercialization of numerous drugs and biologics for various clinical indications. His experiences as a faculty at research-intensive colleges of pharmacy, Group Leader for bioanalytical chemistry at a leading non-for-profit research institute, and General Manager for an international drug-development focused scientific and regulatory consulting firm provide him with a broad, in depth perspective uncommon in analytical laboratories.

Associate Professor
Departments of Pharmacy Practice

Focus of Research:
Dose Optimization and Outcomes Research

Dr. Hall serves as the Vice-Chair of Research for the Department of Pharmacy Practice, Division Head of Clinical and Translational Research, and Director of the Dose Optimization and Outcomes Research (DOOR) program. Dr. Hall work has resulted in over 40 peer-reviewed publications. He has collaborated on grants funded by the Cancer Prevention and Research Institute of Texas, National Institutes of Health, Laura W. Bush Institute for Women鈥檚 Health, as well as the pharmaceutical industry.

Associate Professor
Departments of Pharmacy Practice

Focus of Research:
Pharmacoepidemiology, drug safety and effectiveness

Dr. Alvarez is the Director of the Pharmacoepidemiology Core in the Center. He has expertise in assessing the safety and effectiveness of medications using large-scale administrative claims, and clinical data. Dr. Alvarez has expertise in epidemiologic methods and biostatistical techniques to address inherent biases encountered in pharmacoepidemiology. He has over 30 peer-reviewed publications, is the senior author on the Diabetes chapter of Pharmacotherapy: A Pathophysiologic Approach, and has presented his research at many national and international meetings. His research has been funded by the National Institutes of Health, the Cancer Prevention and Research Institute of Texas, and several private foundations.

Capabilities

Overall, the Clinical Pharmacology & Experimental Therapeutics Center specializes in conducting pharmacology studies on experimental therapeutics.

Specific capabilities of the Center include:

Conduct of Pharmacoepidemiology studies
Conduct of Clinical Outcomes studies
Bioanalytical method development
Bioanalytical method validation
Blood/Plasma/Serum sample analysis
Tissue sample analysis / tissue distribution analysis
Analyte/formulation stability studies
Automated sample preparation
Small molecule bioanalytical sample analysis
Biomolecule bioanalytical sample analysis
Metals analysis
Pharmacokinetic determinations
Targeted metabolite studies
Chemical characterization of small molecules, biotherapeutics, formulated products and botanical extracts
Regulatory development input

Additional services provided by Center faculty:

Program and protocol development and support
Analyses and interpretation of PK and PK/PD data
Population PK analysis for optimal dosing

Facilities

Laboratory space: ~2,500 square feet
General equipment: analytical balances, pipettes, pH meters, centrifuges, two Labconco CentriVap庐 systems, two Nitrogen-evaporation systems, two refrigerators (5 卤 3 掳C), two freezers (-20 卤 10 掳C) and four ultra-freezers (-80 卤 10 掳C). The ultra-freezers are continuously monitored and clinical samples are inventoried using FreezerPro庐 software package. Specialized automated sample preparation equipment includes an Eppendorf epMotion M5073 and a Tomtec Quadra 4庐 automated liquid handling systems.
Tissue preparation equipment: Pro Scientific DPS-20 homogenization system (ultrasonic and mechanical homogenization); Leica RM2255 microtome, Leica CM3050S Cryostat, and a Leica LMP6 laser microdissection system.
Mass spectrometric instrumentation includes: Sciex QTRAP庐 6500+, Sciex QTRAP庐 5500, Sciex TripleTOF鈩� 5600, and an Agilent 7700 ICP-MS. The Sciex QTRAP庐and TripleTOF鈩nstruments can be interfaced with Shimadzu Nexera UHPLC systems or Eksigent exspert鈩ano-LC/micro-LC system. Additional gradient liquid chromatographic (HPLC) systems are available with Shimadzu UV/Vis, ELSD and Dionex electrochemical detectors. Specialized analytical software includes Sciex鈥檚 Analyst鈩�, PeakView鈩�, SWATH鈩�, and MultiQuant鈩� software packages.
Pharmacokinetic modeling software: Certara Phoenix 64 WinNonlin v6.4.

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