Safety pharmacology in and for Africa: establishment of the pre-clinical drug development platform

Abstract Southern Africa (South Africa as well as neighboring countries) has not had an infrastructure for testing the safety of new drugs or other therapeutic entities, including plant-based or herbal treatments coming from the indigenous cultures, according to the current practice and regulatory requirements. Simultaneously, Southern Africa is challenged by very high rates of immune deficiency diseases which have further led to the resurgence of diseases such as tuberculosis, which is commonly thought to be eradicated, at least in Western cultures. Thus, there is high medical need for affordable, effective and safe treatments, but up to now there has been no local expertise and capabilities for state-of-the-art drug testing. Based on an initiative funded by the South African Department of Science and Technology, the Potchefstroom campus of North-West University was chosen for the establishment of a center of excellence for doing rodent-based drug testing research. The centerpiece of the Pre-Clinical Drug Development Platform (PCDDP) is a new rodent vivarium for breeding of SPF rats and mice and associated laboratories for conducting a wide range of physiological and pharmacological studies. Notably, the vivarium has become the first AAALAC-accredited animal facility in Sub-Sahara Africa and is qualified for conducting GLP studies. The establishment of safety pharmacology models is a first priority of the PCDDP, including expertise in studies to examine electrophysiological effects in vitro , and potential CNS, cardiovascular and respiratory effects. The intention is to offer the rodent-based safety pharmacology testing not only to local academic and company-related scientists, but also to those throughout South Africa and neighboring countries.