Regulation of Nanomaterials and Nanomedicines for Clinical Application

Razi Ahmed, Vikash Maurya, Anurag Dwivedi, Manoj Kumar Mishra
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Abstract

Treatment of complicated fatal diseases was difficult when nanotechnology was not more popular. The incorporation of nanomedicine has increased in the last 13 years, even though regulatory guidelines regarding nanomaterials and nanomedicine weren't sufficient. Hence, it was tough to decide valid inevitability for the manufacturers, administrators, health professionals, primary care providers, and rest of the public that could ultimately have a negative impact on the financing system, research, and development of such items, affecting the approval of the public and acceptance of nano-products. This review includes coverage across the therapeutic value of nanomaterials, problems in the regulation, regulatory challenges, synthesis, physicochemical properties, and clinical application. The hurdles to using nanotechnology, particularly in the pharmaceutical development of novel medicinal products and respective regulatory issues, are critically explored, considering the characteristics offered by the nanomaterials.
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对临床应用纳米材料和纳米药物的监管
在纳米技术尚未普及时,治疗复杂的致命性疾病十分困难。在过去的 13 年中,尽管有关纳米材料和纳米医学的监管准则还不够充分,但纳米医学的应用却在不断增加。因此,对于制造商、管理者、卫生专业人员、初级保健提供者和其他公众来说,很难决定有效的必然性,这可能最终会对这些项目的融资系统、研究和开发产生负面影响,影响公众对纳米产品的认可和接受程度。本综述涵盖纳米材料的治疗价值、监管问题、监管挑战、合成、理化特性和临床应用。考虑到纳米材料的特性,对使用纳米技术的障碍,尤其是在新型医药产品的制药开发中的障碍以及相应的监管问题进行了认真探讨。
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