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Clinical Pharmacology & Experimental Therapeutics Center

TTUHSC School of Pharmacy - Dallas (SW Campus)

The Clinical Pharmacology & Experimental Therapeutics Center was founded in 2004 and is located in the Dallas Medical District adjacent to the UT Southwestern Medical Center. The Center’s specific aim is to provide pharmaceutical expertise to support preclinical and clinical/translational trials, including pharmacokinetics/pharmacodynamics, drug metabolism, drug delivery, drug formulations and biomarker identification.

Cores and Specialties

The Clinical Pharmacology & Experimental Therapeutics Center consists of three core areas of focused research:

  • Pediatric Pharmacology Research & Development Core
  • Experimental Therapeutics Core
  • North Texas Clinical Pharmacology Cancer Core (funded in part by CPRIT - the Cancer Prevention and Research Institute of Texas)

The Center’s analytical laboratory specializes in developing and validating automated methods for the analysis of drugs, metabolites and biomarkers contained in complex biologic matrices using state-of-the-art mass spectrometry techniques. UHPLC-MS/MS core instrumentation includes the AB Sciex API 4000™; the QTRAP® 5500 with SelexION™; and the TripleTOF™ 5600. Instrumentation provides the capability to quantitate both small and large molecules -— and with the new SelexION™ — provides the unique capability to separate analytes with identical molecular weights and retention times.

Faculty

Center Director Dr. Richard Leff is a professor of pharmacy practice and the regional dean for the Texas Tech University Health Sciences Center School of Pharmacy (TTUHSC-SOP) in Dallas. He holds a Pharm.D. with a post-doctoral fellowship in pediatric pharmacology. He has served on the faculty at research-intensive colleges of pharmacy for more than 30 years and was the Pediatric Pharmaceutical Development Director at a leading research institute. Dr. Leff has completed clinical and translational studies and has led the development and commercialization of drugs for various clinical indications. His experience includes clinical/translational study design, analytical instrumentation and techniques, data analyses and regulatory affairs.

Laboratory Science Director Dr. Claudia Meek is a research assistant professor for TTUHSC-SOP. She holds a Ph.D. in chemistry with an emphasis in analytical chemistry and she specializes in developing and validating novel methods for analyses of drugs, metabolites and biomarkers. Dr. Meek’s experience with the FDA’s GLP guidelines produces robust analytical methods and data that can be confidently utilized to reliably predict drug pharmacokinetics, safety and efficacy.

Pharmacokinetic Science Director Dr. Reza Mehvar is a professor of pharmaceutical sciences at TTUHSC-SOP. He holds a Pharm.D. and a Ph.D. in pharmaceutics with an emphasis in pharmacokinetics and drug disposition. Dr. Mehvar has extensive experience in preclinical and clinical pharmacokinetic studies.

Facilities

The Clinical Pharmacology & Experimental Therapeutics Center laboratory occupies approximately 1,500 square feet and contains requisite gravimetric balances, pH meters, centrifuges, refrigerators, freezers and pipettes. Specialized instrumentation includes: a Labconco CentriVap® with Cold Trap: a Tomtec Quadra 4® liquid pipetting system; AB Sciex mass spectrometers, including the API 4000™, a QTRAP® 5500 with SelexION™ and a TripleTOF™ 5600. Each mass spectrometer is interfaced with a Shimadzu Nexera UHPLC system, including the SIL-30AC autosampler, CTO-30A column oven and dual LC-30AD pumps for producing binary gradients. Additional gradient liquid chromatographic (HPLC) systems are available with Shimadzu UV/Vis, ELSD and Dionex electrochemical detectors. Specialized software includes MultiQuant™, MetabolitePilot™, MarkerView™, BioAnalyst™ and LightSight®.

Capabilities

The Clinical Pharmacology & Experimental Therapeutics Center laboratory specializes in developing and validating automated micromethods for analyzing drugs, metabolites and biomarkers contained in complex biologic matrices using state-of-the-art mass spectrometry techniques. Capabilities include: (1) analytical method development and validation using U.S. Food and Drug Administration Guidelines (GLP); (2) quantitative analyses of drugs contained in complex matrices, including whole blood, plasma/serum, lung, breast milk, urine, saliva, amniotic fluid, feces and tissues; (3) stability-indicating method development and validation; (4) bioanalytical sample analyses; (5) structural identity and confirmation; and (6) pharmaceutical analytical testing and stability testing.

Center faculty provide: program and protocol development and support; analyses and interpretation of PK and PK/PD data; and population PK analysis for optimal dosing.

Funding

Grant and contract funding for the Clinical Pharmacology & Experimental Therapeutics Center has been sustained since 2004 by the NIH, NICHD, NCI and others. Significant funding ($2.5 million) has recently been awarded by the Cancer Prevention and Research Institute of Texas (CPRIT) to establish the North Texas Clinical Pharmacology Cancer Core.

Authorship

Clinical Pharmacology & Experimental Therapeutics Center collaborators should be included in all publications where significant contribution has been made by core investigators to the research project including consultation, experimental design, method development, and data analyses and/or interpretation. Investigators should be provided the opportunity to review all manuscripts prior to submission for publication. Acknowledgement of the Clinical Pharmacology & Experimental Therapeutics Center and its respective Core is expected in publications that include any data generated by the Center, including work performed on a fee-for-service basis. An example of an appropriate acknowledgement: “The author(s) wish to thank (the respective core; e.g., North Texas Clinical Pharmacology Cancer Core) at the School of Pharmacy, Texas Tech University Health Sciences Center.”

Pricing

Academic pricing is available for research collaborations where the investigators hold primary appointments with institutions of higher education. Due to external funding from the Cancer Prevention & Research Institute of Texas (CPRIT), special pricing is available to support cancer investigations.

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