Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak 124 001, India.
J Biosci. 2021;46.
The growing armamentarium of potential radioisotopes and increased demand for radiopharmaceuticals (RPs) have catapulted their biomedical applications on a trajectory of higher growth in the modern healthcare establishment. Nuclear medicine technology is now regarded as an essential tool for diagnosis, palliation, therapy, and theranostic applications. The associated radiation safety issues need to be emphasized in the form of adequate regulatory action to warrant their safe and effective use. The RPs attracts considerable attention from both pharmaceutical and nuclear regulators due to their constituent pharmaceutical and radioactive components. So, a critical examination of applications of RPs, the latest advances in their development, and the existing regulatory guidelines for RPs have been carried out. This review presents a brief overview of RPs and recent studies on their diagnostic, therapeutic, and theranostic applications. Comprehensive comparative information on regulatory perspectives of RPs in major pharmaceutical jurisdictions such as the United States (US), the European Union (EU), and India reveals ambiguities and heterogeneity. The present studies discuss the importance of RPs in the current healthcare domain, their recent applications, and strive to intensify the concern for an ambient and harmonized regulatory setup.
潜在放射性同位素的不断增加和放射性药物 (RP) 的需求增加，使它们在现代医疗保健领域的生物医学应用呈指数级增长。核医学技术现在被认为是诊断、缓解、治疗和治疗应用的重要工具。需要通过充分的监管行动来强调相关的辐射安全问题，以确保其安全有效使用。由于 RP 含有药物和放射性成分，因此受到制药和核监管机构的高度关注。因此，对 RP 的应用、最新进展以及现有的 RP 监管指南进行了批判性审查。这篇综述简要介绍了 RP 以及最近关于其诊断、治疗和治疗应用的研究。对美国 (US)、欧盟 (EU) 和印度等主要制药管辖区 RP 监管观点的综合比较信息揭示了其中的模糊性和异质性。目前的研究讨论了 RP 在当前医疗保健领域的重要性、它们的最新应用，并努力加强对环境和协调监管框架的关注。
