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

Abstract

BackgroundA 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.ObjectivesThe aim of this article is to describe the development of an IPSL in Zimbabwe.MethodsThe 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.ResultsTwo 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 high-performance 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.ConclusionsAn 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.

Development and validation of a high performance liquid chromatography method to determine nevirapine in plasma in a resource-limited setting

“…A calibration curve was constructed for measuring every batch of validation samples with 1/x 2 weighted linear regression. Six samples were tested at each QC level including LLOQ on 3 days; a different analyst performed the analysis each day.…”

“…Research initiatives supported by several United States National Institutes of Health programmes, experienced mentors and commercial donations have contributed to the establishment of a clinical pharmacology laboratory to support HIV research in Zimbabwe. 2 However, method development and validation present resource and infrastructural challenges in resource-limited settings (RLS).…”

Building resources to meet evolving laboratory medicine challenges in Africa

“…To process laboratory specimens locally, and to the highest standards, it will often be necessary to upgrade or entirely refurbish existing laboratories or plant new ones. While this prospect may be seen as difficult or even daunting, the experiences of others, such as Beyanga et al 11 and Mtisi et al 12 (both this issue) are essential for replicating success and avoiding costly pitfalls. Beyanga et al 11 outline the path of a Tanzanian diagnostic laboratory to accreditation.…”

“…Beyanga et al 11 outline the path of a Tanzanian diagnostic laboratory to accreditation. In their description of the construction of a specialised pharmacology laboratory capable of performing pharmacokinetic analyses, Mtisi et al 12 outline the process from the stage of initiating public-private international partnerships, through human resource development to preparations for ISO 15189 accreditation. Ultimately, as Mtisi et al’s article 12 emphasises, quality must be an initial goal and not an afterthought.…”

Cross-validation of a high-performance liquid chromatography nevirapine plasma assay in a resource-limited setting in Zimbabwe

“…The University of Zimbabwe (UZ) International HIV pharmacology speciality laboratory (IPSL) was established to increase HIV pharmacology-related research and support research investigator capacity in Africa. 1 The UZ-IPSL performs drug development assay and clinical research specimens analyses, specifically drug-drug interactions, pharmacokinetic and pharmacodynamic data analyses.…”