Your browser doesn't support javascript.
loading
Evolution of chemical-specific adjustment factors (CSAF) based on recent international experience; increasing utility and facilitating regulatory acceptance.
Bhat, Virunya S; Meek, M E Bette; Valcke, Mathieu; English, Caroline; Boobis, Alan; Brown, Richard.
Afiliación
  • Bhat VS; a WHO Collaborating Centre on Water and Indoor Air Quality and Food Safety, NSF International , Ann Arbor , MI , USA.
  • Meek MEB; b McLaughlin Centre for Population Health Risk Assessment, University of Ottawa , Ontario , Canada.
  • Valcke M; c Toxicological and Radiological Risk Assessment Group, Institut National de Santé Publique du Québec (INSPQ) , Montreal , Canada.
  • English C; d Department of Environmental and Occupational Health , École de Santé Publique, Université de Montréal (ESPUM) , Québec , Canada.
  • Boobis A; a WHO Collaborating Centre on Water and Indoor Air Quality and Food Safety, NSF International , Ann Arbor , MI , USA.
  • Brown R; e Department of Medicine , Imperial College , London , UK.
Crit Rev Toxicol ; 47(9): 729-749, 2017 Oct.
Article en En | MEDLINE | ID: mdl-28681680
The application of chemical-specific toxicokinetic or toxicodynamic data to address interspecies differences and human variability in the quantification of hazard has potential to reduce uncertainty and better characterize variability compared with the use of traditional default or categorically-based uncertainty factors. The present review summarizes the state-of-the-science since the introduction of the World Health Organization/International Programme on Chemical Safety (WHO/IPCS) guidance on chemical-specific adjustment factors (CSAF) in 2005 and the availability of recent applicable guidance including the WHO/IPCS guidance on physiologically-based pharmacokinetic (PBPK) modeling in 2010 as well as the U.S. EPA guidance on data-derived extrapolation factors in 2014. A summary of lessons learned from an analysis of more than 100 case studies from global regulators or published literature illustrates the utility and evolution of CSAF in regulatory decisions. Challenges in CSAF development related to the adequacy of, or confidence in, the supporting data, including verification or validation of PBPK models. The analysis also identified issues related to adequacy of CSAF documentation, such as inconsistent terminology and often limited and/or inconsistent reporting, of both supporting data and/or risk assessment context. Based on this analysis, recommendations for standardized terminology, documentation and relevant interdisciplinary research and engagement are included to facilitate the continuing evolution of CSAF development and guidance.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medición de Riesgo / Seguridad Química Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Crit Rev Toxicol Asunto de la revista: TOXICOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medición de Riesgo / Seguridad Química Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Crit Rev Toxicol Asunto de la revista: TOXICOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido