World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology

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dc.contributor.authorBarnes, Karenen_ZA
dc.contributor.authorLindegardh, Niklasen_ZA
dc.contributor.authorOgundahunsi, Olumideen_ZA
dc.contributor.authorOlliaro, Pieroen_ZA
dc.contributor.authorPlowe, Christopheren_ZA
dc.contributor.authorRandrianarivelojosia, Milijaonaen_ZA
dc.contributor.authorGbotosho, Graceen_ZA
dc.contributor.authorWatkins, Williamen_ZA
dc.contributor.authorSibley, Carolen_ZA
dc.contributor.authorWhite, Nicholasen_ZA
dc.date.accessioned2015-10-12T10:59:57Z
dc.date.available2015-10-12T10:59:57Z
dc.date.issued2007en_ZA
dc.description.abstractA World Antimalarial Resistance Network (WARN) database has the potential to improve the treatment of malaria, through informing current drug selection and use and providing a prompt warning of when treatment policies need changing. This manuscript outlines the contribution and structure of the clinical pharmacology component of this database. The determinants of treatment response are multi-factorial, but clearly providing adequate blood concentrations is pivotal to curing malaria. The ability of available antimalarial pharmacokinetic data to inform optimal dosing is constrained by the small number of patients studied, with even fewer (if any) studies conducted in the most vulnerable populations. There are even less data relating blood concentration data to the therapeutic response (pharmacodynamics). By pooling all available pharmacokinetic data, while paying careful attention to the analytical methodologies used, the limitations of small (and thus underpowered) individual studies may be overcome and factors that contribute to inter-individual variability in pharmacokinetic parameters defined. Key variables for pharmacokinetic studies are defined in terms of patient (or study subject) characteristics, the formulation and route of administration of the antimalarial studied, the sampling and assay methodology, and the approach taken to data analysis. Better defining these information needs and criteria of acceptability of pharmacokinetic-pharmacodynamic (PK-PD) studies should contribute to improving the quantity, relevance and quality of these studies. A better understanding of the pharmacokinetic properties of antimalarials and a more clear definition of what constitutes "therapeutic drug levels" would allow more precise use of the term "antimalarial resistance", as it would indicate when treatment failure is not caused by intrinsic parasite resistance but is instead the result of inadequate drug levels. The clinical pharmacology component of the WARN database can play a pivotal role in monitoring accurately for true antimalarial drug resistance and promptly correcting sub-optimal dosage regimens to prevent these contributing to the emergence and spread of antimalarial resistance.en_ZA
dc.identifier.apacitationBarnes, K., Lindegardh, N., Ogundahunsi, O., Olliaro, P., Plowe, C., Randrianarivelojosia, M., ... White, N. (2007). World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology. <i>Malaria Journal</i>, http://hdl.handle.net/11427/14203en_ZA
dc.identifier.chicagocitationBarnes, Karen, Niklas Lindegardh, Olumide Ogundahunsi, Piero Olliaro, Christopher Plowe, Milijaona Randrianarivelojosia, Grace Gbotosho, William Watkins, Carol Sibley, and Nicholas White "World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology." <i>Malaria Journal</i> (2007) http://hdl.handle.net/11427/14203en_ZA
dc.identifier.citationBarnes, K. I., Lindegardh, N., Ogundahunsi, O., Olliaro, P., Plowe, C. V., Randrianarivelojosia, M., ... & White, N. J. (2007). World antimalarial resistance network (WARN) IV: Clinical pharmacology. Malaria journal, 6(1), 122.en_ZA
dc.identifier.ris TY - Journal Article AU - Barnes, Karen AU - Lindegardh, Niklas AU - Ogundahunsi, Olumide AU - Olliaro, Piero AU - Plowe, Christopher AU - Randrianarivelojosia, Milijaona AU - Gbotosho, Grace AU - Watkins, William AU - Sibley, Carol AU - White, Nicholas AB - A World Antimalarial Resistance Network (WARN) database has the potential to improve the treatment of malaria, through informing current drug selection and use and providing a prompt warning of when treatment policies need changing. This manuscript outlines the contribution and structure of the clinical pharmacology component of this database. The determinants of treatment response are multi-factorial, but clearly providing adequate blood concentrations is pivotal to curing malaria. The ability of available antimalarial pharmacokinetic data to inform optimal dosing is constrained by the small number of patients studied, with even fewer (if any) studies conducted in the most vulnerable populations. There are even less data relating blood concentration data to the therapeutic response (pharmacodynamics). By pooling all available pharmacokinetic data, while paying careful attention to the analytical methodologies used, the limitations of small (and thus underpowered) individual studies may be overcome and factors that contribute to inter-individual variability in pharmacokinetic parameters defined. Key variables for pharmacokinetic studies are defined in terms of patient (or study subject) characteristics, the formulation and route of administration of the antimalarial studied, the sampling and assay methodology, and the approach taken to data analysis. Better defining these information needs and criteria of acceptability of pharmacokinetic-pharmacodynamic (PK-PD) studies should contribute to improving the quantity, relevance and quality of these studies. A better understanding of the pharmacokinetic properties of antimalarials and a more clear definition of what constitutes "therapeutic drug levels" would allow more precise use of the term "antimalarial resistance", as it would indicate when treatment failure is not caused by intrinsic parasite resistance but is instead the result of inadequate drug levels. The clinical pharmacology component of the WARN database can play a pivotal role in monitoring accurately for true antimalarial drug resistance and promptly correcting sub-optimal dosage regimens to prevent these contributing to the emergence and spread of antimalarial resistance. DA - 2007 DB - OpenUCT DO - 10.1186/1475-2875-6-122 DP - University of Cape Town J1 - Malaria Journal LK - https://open.uct.ac.za PB - University of Cape Town PY - 2007 T1 - World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology TI - World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology UR - http://hdl.handle.net/11427/14203 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14203
dc.identifier.urihttp://dx.doi.org/10.1186/1475-2875-6-122
dc.identifier.vancouvercitationBarnes K, Lindegardh N, Ogundahunsi O, Olliaro P, Plowe C, Randrianarivelojosia M, et al. World Antimalarial Resistance Network (WARN) IV: Clinical pharmacology. Malaria Journal. 2007; http://hdl.handle.net/11427/14203.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Clinical Pharmacologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceMalaria Journalen_ZA
dc.source.urihttp://www.malariajournal.com/en_ZA
dc.subject.otherMalariaen_ZA
dc.subject.otherDrug developmenten_ZA
dc.subject.otherPharmacokineticsen_ZA
dc.titleWorld Antimalarial Resistance Network (WARN) IV: Clinical pharmacologyen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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