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Developing Integrated Approaches for Testing and Assessment (IATAs) in order to support nanomaterial safety.
Powell, L G; Gillies, S; Fernandes, T F; Murphy, F; Giubilato, E; Cazzagon, V; Hristozov, D; Pizzol, L; Blosi, M; Costa, A L; Prina-Mello, A; Bouwmeester, H; Sarimveis, H; Janer, G; Stone, V.
Afiliación
  • Powell LG; Heriot-Watt University, Edinburgh, UK.
  • Gillies S; Heriot-Watt University, Edinburgh, UK.
  • Fernandes TF; Heriot-Watt University, Edinburgh, UK.
  • Murphy F; Heriot-Watt University, Edinburgh, UK.
  • Giubilato E; University Ca' Foscari of Venice, Venice, Italy.
  • Cazzagon V; GreenDecision Srl, Venice, Italy.
  • Hristozov D; University Ca' Foscari of Venice, Venice, Italy.
  • Pizzol L; University Ca' Foscari of Venice, Venice, Italy.
  • Blosi M; GreenDecision Srl, Venice, Italy.
  • Costa AL; Institute of Science and Technology for Ceramics, CNR, Italy.
  • Prina-Mello A; Institute of Science and Technology for Ceramics, CNR, Italy.
  • Bouwmeester H; Trinity College Dublin, The University of Dublin, Dublin, Ireland.
  • Sarimveis H; Division of Toxicology, Wageningen University, Wageningen, The Netherlands.
  • Janer G; National Technical University of Athens, Athens, Greece.
  • Stone V; Leitat Technological Centre, Barcelona, Spain.
Nanotoxicology ; 16(4): 484-499, 2022 05.
Article en En | MEDLINE | ID: mdl-35913849
Due to the unique characteristics of nanomaterials (NM) there has been an increase in their use in nanomedicines and innovative medical devices (MD). Although large numbers of NMs have now been developed, comprehensive safety investigations are still lacking. Current gaps in understanding the potential mechanisms of NM-induced toxicity can make it challenging to determine the safety testing necessary to support inclusion of NMs in MD applications. This article provides guidance for implementation of pre-clinical tailored safety assessment strategies with the aim to increase the translation of NMs from bench development to clinical use. Integrated Approaches to Testing and Assessment (IATAs) are a key tool in developing these strategies. IATAs follow an iterative approach to answer a defined question in a specific regulatory context to guide the gathering of relevant information for safety assessment, including existing experimental data, integrated with in silico model predictions where available and appropriate, and/or experimental procedures and protocols for generating new data to fill gaps. This allows NM developers to work toward current guidelines and regulations, while taking NM specific considerations into account. Here, an example IATA for NMs with potential for direct blood contact was developed for the assessment of haemocompatibility. This example IATA brings together the current guidelines for NM safety assessment within a framework that can be used to guide information and data gathering for the safety assessment of intravenously injected NMs. Additionally, the decision framework underpinning this IATA has the potential to be adapted to other testing needs and regulatory contexts.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas de Toxicidad / Nanoestructuras Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Nanotoxicology Asunto de la revista: TOXICOLOGIA Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas de Toxicidad / Nanoestructuras Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Nanotoxicology Asunto de la revista: TOXICOLOGIA Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido