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Developing radiopharmaceutical drugs and regulation perspective process in United States
Developing radiopharmaceutical drugs and regulation perspective process in United States
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Summary
Developing radiopharmaceutical drugs and pharmaceutical products United States and Europe. The research paper examined the differences between developing radiopharmaceutical drugs and pharmaceutical product in regulation perspective in United States and Europe. In particular, dominant themes about radiopharmaceuticals includes therapeutic and diagnosis. Apart from the introduction section that commences the study, the significance of the study was outlined as well. When it comes to the significance of the study, it became apparent that the study on radiopharmaceuticals will help to comprehend the vital effect on surgical operations and diagnostics. In addition, the paper reviewed different studies on radiopharmaceutical drugs, in a bid to establish the underlying differences. In the US, for instance, the study noted that FDA is at the centre of radiopharmaceutical approval, while EudraLex is squarely responsible in Europe. In addition, the study determined that regulatory framework in Europe is anchored on a set of legal instruments, which are guided by the European Commission (EC). With different legislative mechanisms, the EU has the ability to entrench different laws and policies across the EU. When it comes to the research methods, the study adopted a qualitative study to explore and comprehend approval disparities between US and Europe. Owing to the exploratory nature of the study method, the research was able to provide understandings on differences that underlay drug development and perspectives about the regulation process. The qualitative approach was bolstered by evaluating previous findings on the authentications of radiopharmaceuticals in Europe and USA. Results are vividly presented using figures and tables. Limitations and strengths of the study are also outlined. Whereas recommendations for future studies are proposed, the research paper wraps up with a substantive conclusion.
