Strategic establishment of an International Pharmacology Specialty Laboratory in a resource-limited setting

African Journal of Laboratory Medicine

Field Value
Title Strategic establishment of an International Pharmacology Specialty Laboratory in a resource-limited setting
Creator Mtisi, Takudzwa J. Maponga, Charles Monera-Penduka, Tsitsi G. Mudzviti, Tinashe Chagwena, Dexter Makita-Chingombe, Faithful DiFranchesco, Robin Morse, Gene D.
Subject Pharmacology Pharmacology Specialty laboratory systems; therapeutic drug monitoring
Description Background: A growing number of drug development studies that include pharmacokinetic evaluations are conducted in regions lacking a specialised pharmacology laboratory. This necessitated the development of an International Pharmacology Specialty Laboratory (IPSL) in Zimbabwe.Objectives: The aim of this article is to describe the development of an IPSL in Zimbabwe.Methods: The IPSL was developed collaboratively by the University of Zimbabwe and the University at Buffalo Center for Integrated Global Biomedical Sciences. Key stages included infrastructure development, establishment of quality management systems and collaborative mentorship in clinical pharmacology study design and chromatographic assay development and validation.Results: Two high performance liquid chromatography instruments were donated by an instrument manufacturer and a contract research organisation. Laboratory space was acquired through association with the Zimbabwe national drug regulatory authority. Operational policies, standard operating procedures and a document control system were established. Scientists and technicians were trained in aspects relevant to IPSL operations. A highperformance liquid chromatography method for nevirapine was developed with the guidance of the Clinical Pharmacology Quality Assurance programme and approved by the assay method review programme. The University of Zimbabwe IPSL is engaged with the United States National Institute of Allergy and Infectious Diseases Division of AIDS research networks and is poised to begin drug assays and pharmacokinetic analyses.Conclusions: An IPSL has been successfully established in a resource-limited setting through the efforts of an external partnership providing technical guidance and motivated internal faculty and staff. Strategic partnerships were beneficial in navigating challenges leading to laboratory development and training new investigators. The IPSL is now engaged in clinical pharmacology research.
Publisher AOSIS
Contributor National Institutes of Health [grant numbers 7UMIA1068636-07, 1D4TW007991-01A2, 2U2RTW007367, D43TW007991-01A2 and D43TW010313-01] Waters Associates, Inc Research Triangle International (RTI) Merck Laboratories
Date 2018-02-12
Type info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion — —
Format text/html application/epub+zip application/xml application/pdf
Identifier 10.4102/ajlm.v7i1.659
Source African Journal of Laboratory Medicine; Vol 7, No 1 (2018); 6 pages 2225-2010 2225-2002
Language eng
Relation info:eu-repo/grantAgreement/EC/FP7/078498
Coverage — — —
Rights info:eu-repo/semantics/openAccess Copyright (c) 2018 Takudzwa J. Mtisi, Charles Maponga, Tsitsi G. Monera-Penduka, Tinashe Mudzviti, Dexter Chagwena, Faithful Makita-Chingombe, Robin DiFranchesco, Gene D. Morse