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Regulatory roadmap for nanotechnology based medicines

  • Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide range of sectors that can benefit citizens. Nanomedicine is an application of nanotechnology in the areas of healthcare, disease diagnosis, treatment and prevention of disease. Nanomedicines pose problem of nanotoxicity related to factors like size, shape, specific surface area, surface morphology, and crystallinity. Currently, nanomedicines are regulated as medicinal products or as medical devices and there is no specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.

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Author:Vaidehi Limaye, Gerhard FortwengelORCiDGND, Dnyanesh LimayeORCiDGND
Parent Title (English):International Journal of Drug Regulatory Affairs
Document Type:Article
Year of Completion:2014
Publishing Institution:Hochschule Hannover
Release Date:2017/05/30
Tag:Approval; Nanomedicine; Nanotechnology; Nanotoxicity; Regulations
First Page:33
Last Page:41
Link to catalogue:1749508796
Institutes:Fakult├Ąt III - Medien, Information und Design
DDC classes:610 Medizin, Gesundheit
Licence (German):License LogoCreative Commons - CC BY-NC - Namensnennung - Nicht kommerziell 4.0 International