Resources

Drug Assay Directory

The Drug Assay Directory is a searchable database, downloadable as an excel spreadsheet, sorted by clinical pharmacology laboratories (CPL), developed by the CPQA Program. The Drug Assay Directory allows users to easily identify the CPQA approved assay methods at DAIDS-funded CPLs. The database includes each assay’s details for acceptable specimen collection, processing and storage, as well as other pertinent information.

CPQA PT Program Guidelines

This document provides an overview of the Proficiency Testing Program, the responsibilities of testing laboratories, and an explanation of the proficiency testing process.

Assessment SOP (Standard Operating Procedure)

This document is a guideline that describes the CPQA assessment practices and procedures. The purpose of the CPQA assessment is to identify appropriate quality recommendations for the development, implementation or operations of the laboratory assessed. This document is for informational purposes and provides guidance for the potential laboratory assessment candidates such as laboratory resources, facilities, operations, qualifications and documentation.

AVR/SOP Guidance (Analytical Validation Report/Standard Operating Procedure Guidance)

This guidance document represents recommendations from CPQA for validating bioanalytical methods for use in analyzing NIAID/DAIDS study specimens. These recommendations were adopted from the May 2001 US Food and Drug Administration (FDA)’s Guidance for Industry: Bioanalytical Method Validation, regulatory agency/industry, consensus opinions from the December 2013 Crystal City V Meeting, and best practices published in industry white papers. It is strongly recommended that, at a minimum, CPQA participating CPLs follow these CPQA guidelines as described in this document for validating and performing analyses for NIAID/DAIDS sample applications.

Browne RW, Rosenkranz SL, Wang Y, Taylor CR, DiFrancesco R, Morse GD. (2019). Sources of Variability and Accuracy of Performance Assessment in the Clinical Pharmacology Quality Assurance (CPQA) Proficiency Testing Program for Antiretrovirals. Therapeutic Drug Monitoring, 41(4):452-458. PMCID: PMC6629475

Mtisi TJ, Maponga CC, Monera-Penduka TG, Mudzviti T, Chagwena D, Makita-Chingombe F, DiFrancesco R, Morse GD. Strategic establishment of an International Pharmacology Specialty Laboratory in resource-limited setting. African Journal of Laboratory Medicine. 2018 Feb; 7(1): 659-64. PMCID: PMC5843799

DiFrancesco R, Taylor CR, Rosenkranz SL, Tooley KM, Pande, PG, Siminski, SL, Jenny, RW and Morse GD. Adding Value to Antiretroviral Proficiency Testing. Bioanalysis. 2014 Oct;6(20):2721-32. PMCID: PMC4296581

DiFrancesco R, Rosenkranz SL, Taylor CR, Pande PG, Siminski SM, Jenny RW, Morse GD. Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories. Ther Drug Monit. 2013 Oct;35(5):631-42. PMCID: PMC3781596

Difrancesco R, Tooley K, Rosenkranz SL, Siminski S, Taylor CR, Pande P, Morse GD. Clinical Pharmacology Quality Assurance for HIV and Related Infectious Diseases Research. Clin Pharmacol Ther. 2013 Mar 26. PMCID: PMC3970711

Francesco R, Maduke G, Patel R, Taylor CR, Morse GD. Antiretroviral Bioanalysis Methods of Tissues and Body Biofluids. Bioanalysis. 2013 Feb;5(3):351-68. doi: 10.4155/bio.12.319. PMCID: PMC3836712.