HIV/AIDS Clinical Pharmacology Quality Assurance and Quality Control (CPQA) Program
The HIV/AIDS Clinical Pharmacology Quality Assurance (CPQA) program and laboratory are located at the UB Pharmacotherapy Research Center on the University at Buffalo (UB) North (Amherst) Campus. CPQA work will also be conducted at the Translational Pharmacology Research Core in the New York State Center for Excellence in Bioinformatics and Life Sciences in downtown Buffalo.
The mission of the Clinical Pharmacology Quality Assurance and Quality Control (CPQA) program is to develop and conduct quality assurance activities that support the HIV/AIDS translational research and clinical trials within DAIDS networks to facilitate the following:
Pharmacology Laboratories and Antiretroviral Assays
- Assure assays conducted in Pharmacology Specialty Laboratories (PSLs) are accurate, reproducible, and rugged;
- Assure laboratories that conduct assays apply good laboratory, safety, quality control/assurance, organizational, and management practices;
- Provide quality reagents to the PSLs for the purposes of proficiency testing and assay development and validation;
- Assure pharmacology laboratory assay results from PSLs are accurate; and
- Assay development, validation and method transfer to PSLs for implementation.
Review of Antiretroviral Assay Validation Reports (AVR) and Method Standard Operating Procedures (SOP)
- Provide assay quality review for PSLs.
Antiretroviral Proficiency Testing (PT) Program
- Conduct antiretroviral proficiency testing for domestic and international Pharmacology Specialty Laboratories.
Domestic and International Laboratory Staff Training
- Assist and train PSL personnel to conduct assay development, validation and implementation.
Domestic and International Clinical Research Staff Training
- Provide training to clinical trial personnel for the quality conduct of pharmacology studies.
- Publish and disseminate results to improve the quality of pharmacology measurements made in clinical trials.