Mapping of the available standards against the regulatory needs for nanomedicines
| Autor: | Susanne Bremer-Hoffmann, Alessia Bogni, Uwe Holzwarth, Gert Roebben, Blanka Halamoda-Kenzaoui |
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| Rok vydání: | 2018 |
| Předmět: |
Standardization
regulatory uncertainties Process (engineering) Biomedical Engineering Medicine (miscellaneous) Bioengineering 02 engineering and technology information requirements Gap analysis 010402 general chemistry 01 natural sciences Scientific evidence Order (exchange) Animals Humans Relevance (information retrieval) Drug Approval preclinical characterization business.industry personalized medicine Reference Standards 021001 nanoscience & nanotechnology nanomedicines Social Control Formal 0104 chemical sciences 3. Good health Drug Liberation Nanomedicine Risk analysis (engineering) Advanced Review Anticipation (artificial intelligence) standards Advanced Reviews Business Personalized medicine 0210 nano-technology Regulatory and Policy Issues in Nanomedicine |
| Zdroj: | Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology |
| ISSN: | 1939-0041 1939-5116 |
| DOI: | 10.1002/wnan.1531 |
| Popis: | Appropriate documentary standards and reference materials are crucial building blocks for the development of innovative products. In order to support the emerging sector of nanomedicine, relevant standards must be identified and/or developed before the products will enter into the regulatory approval process. The anticipation of standardization needs requires a good understanding on the regulatory information requirements that can be triggered by the particularities of nanomedicines. However, robust datasets allowing firm conclusions on regulatory demands are not yet available due to a lack of regulatory experience with innovative products. Such a catch-22 situation can only be advanced in an iterative process by monitoring continuously the scientific evidence and by promoting intensive knowledge exchange between all involved stakeholders. In this study, we have compiled information requirements released by regulatory scientists so far and mapped it against available standards that could be of relevance for nanomedicines. Our gap analysis clearly demonstrated that for some endpoints such as drug release/loading and the interaction of nanomedicines with the immune system no standards are available so far. The emerging nanomedicine sector could benefit from cross-sector collaboration and review the suitability of standards that have been developed for nanomaterials used for other industrial applications. Only a concerted action of all parties can lead to a smooth translation of nanomedicines to clinical application and to the market. This is in particular important because nanotechnology-based drug delivery systems are key for the development and implementation of personalized medicine. This article is characterized under: Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine. |
| Databáze: | OpenAIRE |
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