Mtisi Takudzwa J, Maponga Charles, Monera-Penduka Tsitsi G, Mudzviti Tinashe, Chagwena Dexter, Makita-Chingombe Faithful, DiFranchesco Robin, Morse Gene D
International Pharmacology Specialty Laboratory, School of Pharmacy, University of Zimbabwe College of Health Sciences, Harare, Zimbabawe.
Center for Integrated Global Biomedical Sciences, University at Buffalo, Buffalo, New York, United States.
Afr J Lab Med. 2018 Feb 12;7(1):659. doi: 10.4102/ajlm.v7i1.659. eCollection 2018.
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.
The aim of this article is to describe the development of an IPSL in Zimbabwe.
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.
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 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.
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.
越来越多包含药代动力学评估的药物研发研究在缺乏专业药理实验室的地区开展。这使得在津巴布韦建立一个国际药理专业实验室（IPSL）成为必要。
本文旨在描述津巴布韦IPSL的建立情况。
IPSL由津巴布韦大学和布法罗大学全球生物医学科学综合中心合作建立。关键阶段包括基础设施建设、质量管理体系的建立以及在临床药理学研究设计、色谱分析方法开发与验证方面的合作指导。
一家仪器制造商和一家合同研究组织捐赠了两台高效液相色谱仪。通过与津巴布韦国家药品监管机构合作获得了实验室空间。建立了操作政策、标准操作规程和文件控制系统。对科学家和技术人员进行了与IPSL运营相关方面的培训。在临床药理学质量保证计划的指导下开发了一种奈韦拉平的高效液相色谱方法，并经分析方法审查计划批准。津巴布韦大学IPSL与美国国立过敏与传染病研究所艾滋病研究网络部门合作，准备开始药物分析和药代动力学分析。
通过外部伙伴关系提供技术指导以及内部积极的教职员工的努力，在资源有限的环境中成功建立了一个IPSL。战略伙伴关系有助于应对导致实验室发展和培训新研究人员的挑战。IPSL现已从事临床药理学研究。
