Assignment - Write the Dissertation on Radiopharmaceuticals.

Develop the research method section of your prospectus which includes; the Operational Definition of Variables, Measurement, and the Summary.

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Answer -

Introduction

In the current days the increasing demand of radioactive isotopes resulted in price increment for the associated products to it. In addition to this, the low production causes further price increment and makes it difficult to easily access by the demanding industries. Therefore, it is required to assess the issues and related literatures to find a way to resolve the issues.

Statement of the Problem

According to reports, the demands for radioactive isotopes are high and increasing day by day, while the production is subsequently low. This issue, according to the report of The British Nuclear Medicine Society, imposed serious negative effect on medical filed. They stated the evidences of patient death due to insufficiency of 99Mo products in several situations. In addition to this, vulnerability has been detected in shipping, due to insufficient supply and the world may experience severe shortage of the valuable medicines in future.

Purpose of the Study

The purpose of the study is to assess different research questions and associated literatures and evaluate the research methods to find the solutions to the problem stated previously.

Research Questions

The research questions are as following:

• Do the research finds the satisfactory answers to the issues assed in the report?
• What could be the most effective approaches to improve the production of radioactive isotopes?
• What methodology can be used to conduct the appropriate study?

Hypotheses

The current report will focus to find the solutions for above stated issues, which could possibly be helpful to resolve the problems. The outcome of the research could shed light on different methods and measurements, which will help to increase the production of radioactive isotopes and perhaps, influence the pricing and make it cost-effective.

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Brief Review of the Literature

Evidences for Increased Demand for Radioactive Isotopes Worldwide

According to the World Nuclear Association (WNA), radiation is the most critical aspect in nuclear medicine used to make a diversity of diagnostic procedures. Moreover, radio-isotopes have been found to be highly efficient in nuclear medicine diagnostics, fueling their demand worldwide. According to this report, over 10000 health institutions in different parts of the world are already using nuclear medications to diagnose and treat and treat patients. Particularly, in developed countries, one out of 50 people are diagnosed and treated using nuclear medications (Hoehr et.al, 2017). This in itself indicates that the demand is certainly very high globally. Consequetly, as outlined by (Borgna et.al, 2017) the high demand certainly leads to its scarcity and subsequently high cost. The implication of this trend is that many people, especially those from the low class caliber may not be a position to access these medications irrespective of how much they may need them.

In his research, Metello (2015) found out that Technetium 99-metastable (99mTc) has since 1960s remained to be the most critical radionuclide employed in clinical medicine. Moreover, the author realized that the high reliance on this product for this long time has been attributed to its production in low quantities of old nuclear reactors and hence jeopardizing on its dependability. Other reasons include the high dependence of 99mTc on enriched uranium, poor infrastructure for processing purposes and ineffective production processes. These and many other challenges have curtailed the overall supply and quantity of 99mTc produced subsequently leading to high costs and prices. In this regard, a need for alternative reimbursement models is needed to lower the cost of production and increase the supply.

A survey undertaken by the National Academy of Sciences established that the medical isotope isotope molybdenum-99 (Mo-99), and iodine-131 (I-131, and xenon-133 (Xe-133), are popularly used in various parts of the world especially in the field of medical imaging and therapy. According to the report, the United States alone consumes around 50% of the global Mo-99 supply. Besides, the product is imported from such countries as Australia, Canada, Europe, and South Africa. It is interesting to note that America still imports Mo-99 supply despite being regarded as a superpower and with adequate resources to produce the isotope locally.

Implications for Increased Demand and Low Supply of Medical Radioisotopes

According to an article by Glubrecht (2015), there are many fields that are applying radioactive isotopes for different purposes. These include the scientific environment, the technical world, agriculture, industrial production, and even in academic and scientific research. This wide use has lead to an escalated demand worldwide. Consequently, this necessitates formulation of approaches to increase the production and accessibility of medical isotopes for reliability purposes and price regulation in the medical field. It should be considered that many governments in the world in general are focused at creating an assessable and free Medicare to citizens. In order to achieve this goal, there is absolutely a need to strategize on how the production of radioactive isotopes can be sustained and improved. This includes finding alternative and cheap ways of producing them.

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Recently, there has been a general increase of prices for prescription drugs in all aspects (including radioisotopes) in the U.S and around the world. Consequently, a number of drugs and medications have become unreachable for poor members of the society. Accordingly, governments have been required to institute measures to ensure that the required drugs are made available to citizens at all costs. Similar findings were found by Walker (2017) who noted that many countries do not have adequate regulations governing medical isotopes production and distributions. Consequently, this has resulted to various issues such as unsustained supply, exploitation of patients and customers by pharmaceuticals, lack of competition, high cost of the medical productions, and lack of incentives to manufacturers and dealers.

Schwarz (2015) assessed the implication for unsustainability of Mo99 production in the United States in particular. Accordingly, he noted that the interruption of supply jeopardized the accurate of medical tests and diagnostic results on patients. On the other hand, the costs of the medical diagnosis turned to be high while some users were unable to assess them. This showcases the need for a sustained supply for effective and accurate results as well as friendly prices for users.

Radioisotopes used in Nuclear Medicine

Boschi and Spinelli (2015) discusses about the application of new emerging applications of Cerenkov radiation (CR), and radioluminescence imaging (RI), for pre-clinical imaging of small animal. The new emerging radioisotopes are becoming increasingly used in monitoring radionuclide and for external radiotheraphy among human beings. CR in particular is used in 3D reconstruction techniques for Cerenkov images alongside its use as excitation source for endoscropic imaging. Boschi and Spinelli also reviewed the development of microfluidic chips to monitoring radiochemical fusion. On the other hand, radioluminescence imaging has also been popularly used in detecting the use of gamma and alpha emitters.

As observed by Hou et al (2012), there are three main technetium agents which are commonly utilized in nuclear medicine diagnostics. They include: sestamibiTM, phosphonates and pertechnetate. Furthermore, cyclotron is also found to be a stable isotope among other isotopes. Cerenkov luminescence imaging (CLI) as explained by Ma et al (2014), is a new tool developed after combination of optical imaging and nuclear medicine imaging to develop a novel imaging modality that is used for biological experiments. The resulting too is more effective and efficient regarding diagnostic outcomes.

Khlopkov, Pomper and Chekinadiscusses (2015) points out that Molybdenum-99 which is a medical isotope is used in over 80% of the medical procedures which involve isotopes. The authors further argue that to enhance the global supply and sustainability of Molybdenum-99, there is a need to transform from HEU to LEU to aid the cost management of its productions. Waish (2017) also identifies Actinium-225, as one of the most effective radioactive isotope used to treat conditions related with cancer.

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The article by WebElements (2019) analyzes different Germanium isotopes and how they are used to produce medicalAs and Se radioisotopes. According to the author, not all radioisotopes are used medically. For instance, Ge-74, As-74, are Germain isotopes used in producing medical radioisotopes while Ge-72, Ge-74 are used to manufacture biological agents etc. The author also point out that the different germanium radioisotopes have got different masses, models of decay and magnetic capabilities. This thus requires producers and pharmaceuticals to select the most appropriate elements for production of medical radioisotopes. This is important for the durability of the final product, and its effectiveness in medical tests and therapeutic outcome. In other words, a consideration of the elements constituting the raw materials to make a certain radioactive isotope for medical purposes is quite critical in the field of nuclear medicine.

Ways of Increasing Production and Sustainability of Medical Radioisotopes

One of the ways to reduce the cost of producing radioisotopes as observed by Ragheb (2017) is through efficient management of waste. According to the author, management of radioactive waste is important to ensuring that the raw materials are used as economically as possible while the expenses to mitigate the environmental impact of such a waste are leveraged. This will thus help to keep in check the cost of production which will translate to favorable prices to end users. At the same time, the impact to the environment of their environment will be checked and thus the company involved in production will not have to incur huge costs of addressing the associated impact of huge wastes from productions.

On his part, Forrest (2015), advocates the use of Cyclotron to enhance the production of technetium-99m (Tc-99m). According to the research conducted by Forest, Tc-99m produced by cyclotron had higher image quality similar to Tc-99m produced through a nuclear reactor. Other advantages of using cyclotron against nuclear reactors or enriched uranium are its cost effectiveness and it being more environmentally friendly.

As observed by Migdal and Krok (2014), the high cost of radioactive isotopes in the medical field are largely associated with the elements and raw materials comprising them. However, as exemplified in the constant modification of the Maria Reactor by Poland which has since 2005 been transformed from a highly enriched HEU fuel to a low enriched (LEU) one with 235U content below 20%, there is a possibility of modifying existing radioisotopes and nuclear reactors either upwards or downwards with an aim of reducing production costs and expenses.

To encourage pharmaceuticals and manufacturers to produce medical isotopes Gannon (2017) proposes the use of ASP model, which is presumed to facilitate timelier reimbursement to research firms and companies involved in production of medical isotopes. The author opines that if these companies and researchers are adequately and affectively facilitated, there is a higher likelihood that the production of isotopes will rise to sustainable levels. This is because many researchers will rise to the occasion and maybe find alternative cost-effective production approaches while companies will be in a position make the productions without financial obstacles that are hindering many others from the same.

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Summary

Generally, the review validates increased demand of medical radioisotopes on the global scale. Furthermore, the author has also identified that in most cases, the production methods are ineffective, leading to scarcity, and high prices. The result is inaccessibility of the needed drugs to a large number of users due to funds limitations, poor tests and in some cases deaths. However, there exists alternative methods of productions which if well implemented can lead to sustainability and hence production of medical radioisotopes.

Radioactive isotopes: It is referred as radioisotope, radionuclide or any type of various species of the similar chemical component with distinctive masses whose nuclei are not stable as well as dissipate excess energy through spontaneously emitting radiation in the form of alpha, beta as well as gamma rays.

World Nuclear Association: It is the international organisation, which promotes nuclear power as well as supports the organisations that comprise the global nuclear industry.

British Nuclear Medicine Society: It has worked with the royal college of radiologists as well as the UK radio pharmacy group to generate practical guidance for helping nuclear teas plan.

Research Method

The research method can be described as the foundation of the whole research work, in which several research methods are carried out to propose the study. The research paper is demonstrated by both qualitative and quantitative methods of research and additionally the constructive method of research is also used in the report.

Rationale:

The report looks for the answers of the quantitative question of finding a satisfactory answer. It seems that the report will be able to find and suggest appropriate solutions for the problems.

As the answer to the qualitative question regarding the process of production improvement, it can be decided that use of advanced technologies can be an effective process. Another solution can be suggested as the utilization of traditional medical cyclotron to confirm the production of the 99Mo, which can ensure to address the issues of shortage in supply.

The constructive question focuses to the construction of the research paper. The research paper is academic and thus it uses a detailed work of reach, evaluating associated literature and qualitative and quantitative data, which will be helpful to conduct the whole research work.

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Operational Definition of Variables

The quantitative data provides the variables for the study, such as:

The number of people using the 99Mo around the globe:

According to the report by the National academy of Sciences, Engineering and Medicine, the half of the total production of 99Mo was being used by the US and the rest of the world used other half.

The variables are the regions across the world. One is the US and other is the rest of the world.

Measurement

Adherence to a proper methodology helps in the achievement of successful completion of the allocated projects. Possession of a certain philosophical approach helps in the execution of the research as per the chalked out framework. Along with this, collection of data through a proper analytical tool helps the researcher to analyse the collected data in an efficient manner. Herein, lays the equal placement of data collection and data analysis in the equal alignment. Viewing it from another perspective, these components can be considered as the common thread, which leads to the methodological perspective towards the execution of research on the insecurities of people during online transactions.

Research Onion

In spite of being a complex structure, research onion prove helpful in gaining clarity about the methodology for carrying out the research project (Kumar 2019). Segmentation of the components of methodology contradicts the complexity of the structure. The spiral structure finds its applicability in the fourth chapter, where analysis of the collected data reveals the appropriateness of the selected methodology.

Research Design

The researcher, in order to conduct a research project, follows an integrated design. This adherence leads to the achievement of positive outcomes. In case of this research, the researcher would choose descriptive design. (Bresler and Stake 17) Online transactions are a vast and diversified concept. Conducting a research on this topic needs in-depth research. This depth projects the justification of descriptive design, which would allow the researcher to delve deep into every aspect of transactions that are carried out online.

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Research Philosophy

Following a certain philosophy helps in the achievement of success in terms of performance of the tasks. This proves true even for the execution of research on online transactions. Positivism, interpretivism and post-positivism attain commonality in case of carrying out research projects (Fletcher 2017). Selection of positivism philosophy would prove fruitful in the development of facts based on scientific knowledge. Taking into consideration, the scientific facts related to online transactions would result in the establishment of their effectiveness in terms of customer satisfaction. Assistance from charts, graphs and tables would enliven the hazards that destroy the prospects of online transactions. The non-selection of realism and interpretivism aligns with the specific requirements of the research to be conducted.

Research Approach

Possession of a particular approach enhances the hope for positive outcomes. This is even applicable in case of the execution of research project. Inductive and deductive are the two kinds of approach, with which the researchers conduct the research. Inductive theory paves a new way for the research through the consideration of the pre-existing theoretical framework. In this process, the focus of the researcher gets transferred from research to analysis, which is a deviation towards the execution of research (Cuervo-Cazurra et al. 2017). On the contrary, deductive approach enhances the imagination and creativity of the researcher. This is in reference to the deduction of relevant facts, ideas and concepts from the gathered and available sources. This action leads the research on a right track.

The researcher would choose deductive approach for conducting research on online transactions. This deduction would help the researcher to establish facts, which project the insecurity of the individuals in the process of online transactions. Along with this, deductive approach proves beneficial in establishing the realities of the insecurities encountered by the individuals in the online transactions. Herein, lays the effectiveness of hypothesis.

Data Analysis process

Analysis holds prime importance in terms of judging the effectiveness of the collected data. Mainly primary and secondary data analysis tools are used for analyzing the appropriateness of the collected data. Primary analysis is carried out through the help of pictorial representation of the sample responses. On the other hand, secondary analysis is mainly done through the means of excavating certain themes relevant to the proposed research topic. In this current research, the researcher would adopt thematic analysis as it assists the researcher to enliven the security issues, which act as an obstacle for the individuals in the process of online transactions. Linkages of these themes with the theories would lead to the deduction of relevant conclusions and recommendations.

The quantitative data has been collected via several interviews during the surveys around the world. The data provided by the studies are measured with a numerical method and evaluated with different variables to analyse.

Qualitative data has been collected and constructed from and around different surveys and journal reports by different researches. The data has been analysed through step by step development of the survey report. Primary qualitative studies focused to the information from different interviews and organisational researches to collect and analyse related information. The information provides required statistics to produce the answers against the research questions.

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The constructive data can be justified by the attempts of making a detailed research report and stating a detailed research methodology. The constructive data focuses to find the similar problems world-wide and describes solutions, comparing the data. The data was analysed to provide the research methods of current paper.

Ethical consideration

Every action possesses certain considerations, adherence to which helps in the preservation of the moral codes and ethics. This is applicable even for the execution of this research on insecurities within online transactions. As a matter of specification, compliance to Data Protection Act (1998) would help the researcher to safeguard the personal data of the customers. This adherence would mitigate the instances of cyber crimes, which possesses enough flexibility for building up trust, loyalty and dependence of the customers. Along with this, the researcher would attempts to acknowledge the works of the others through proper citations, which would lessen the plagiarism percentile. Apart from this, the research would comply with the ethics, codes and standards of IT legislations, which directly addresses the requirements of the research.

Limitations of the study

Time and financial constraints bear direct correlation with the limitations, which might act as an obstacle for the researcher in deducing conclusions and suggestion of recommendations. Availability of sufficient time would have enabled the researcher to carry out both qualitative and quantitative research.

Summary

The report is focused to evaluate the issues regarding the shortage of radio-isotope supplies in worldwide medical field. The report introduces the subject and the issues, around which the research has been constructed. The research looks for the problem of low production of radioactive isotopes which has been high in demand in different fields of medical industries. The low production heavily impacts on the cost of these highly essential and demanding elements for patient treatment. Thereafter, the report described three research questions of quantitative, qualitative and constructive research methods. The quantitative question seeks the answer for the satisfactory answer or solution, provided by the current report and the answer found to be positive. The qualitative question looks for the effective methods to improve the production of radioactive elements that are used in medical purposes and provides the answers as described in the rationale after assessing the literature review. The constructive question asks for the research methodology, which is crucial to construct a proper research framework to justify the answers.

The literature review has been discussed and assessed in the next chapter, describing two different scenarios or researches. The first report was explained by the WNA, which stated the rate of demand increment. The theme also reported the number of people is approximately 1 out 50 in developing countries, who are diagnosed by99mTc isotope. The second theme reports the usage of another highly demanding radioactive isotope, 99Mo and provides the information that the 505 of total production is consumed by the US only. The report also stated the cause behind the cost increment was the import of the elements from different countries around the world.

In the next chapter different methods of the research has been discussed including a brief rationale. The variables and other measurement of data has been described.

Conclusion

The report looks for the issues of radio isotope supplies in the medical industries. The issue identified as the shortage of supply and high price of the elements. Thus was required to look for a solution to these issues to improve the production of required elements. Assessing the whole report, it can be concluded that, improving the infrastructure and implementing new technologies to resolve the issues.

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