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dc.contributor.authorGuth, Brian D.
dc.contributor.authorGrobler, Anne F.
dc.contributor.authorFrazier, Kendall S.
dc.contributor.authorGreiter-Wilke, Andrea
dc.contributor.authorHerzyk, Danuta
dc.date.accessioned2019-06-04T13:12:52Z
dc.date.available2019-06-04T13:12:52Z
dc.date.issued2019
dc.identifier.citationGuth, B.D. et al. 2019. Drug safety Africa: an overview of safety pharmacology & toxicology in South Africa. Journal of pharmacological and toxicological methods, 98: Article no 106579. [https://doi.org/10.1016/j.vascn.2019.106579]en_US
dc.identifier.issn1056-8719
dc.identifier.issn1873-488X (Online)
dc.identifier.urihttp://hdl.handle.net/10394/32500
dc.identifier.urihttps://www.sciencedirect.com/science/article/pii/S1056871919300395
dc.identifier.urihttps://doi.org/10.1016/j.vascn.2019.106579
dc.description.abstractThis meeting report is based on presentations given at the first Drug Safety Africa Meeting in Potchefstroom, South Africa from November 20–22, 2018 at the North-West University campus. There were 134 attendees (including 26 speakers and 34 students) from the pharmaceutical industry, academia, regulatory agencies as well as 6 exhibitors. These meeting proceedings are designed to inform the content that was presented in terms of Safety Pharmacology (SP) and Toxicology methods and models that are used by the pharmaceutical industry to characterize the safety profile of novel small chemical or biological molecules. The first part of this report includes an overview of the core battery studies defined by cardiovascular, central nervous system (CNS) and respiratory studies. Approaches to evaluating drug effects on the renal and gastrointestinal systems and murine phenotyping were also discussed. Subsequently, toxicological approaches were presented including standard strategies and options for early identification and characterization of risks associated with a novel therapeutic, the types of toxicology studies conducted and relevance to risk assessment supporting first-in-human (FIH) clinical trials and target organ toxicity. Biopharmaceutical development and principles of immunotoxicology were discussed as well as emerging technologies. An additional poster session was held that included 18 posters on advanced studies and topics by South African researchers, postgraduate students and postdoctoral fellowsen_US
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.subjectDrug safetyen_US
dc.subjectSafety pharmacologyen_US
dc.subjectClinicalen_US
dc.subjectTranslationen_US
dc.subjectToxicologyen_US
dc.subjectBiologicalen_US
dc.subjectPathologyen_US
dc.titleDrug safety Africa: an overview of safety pharmacology & toxicology in South Africaen_US
dc.typeArticleen_US
dc.contributor.researchID26801124 - Guth, Brian Douglas
dc.contributor.researchID11008857 - Grobler, Anne Frederica


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