¶ … dosage levels of Cholestease on Serum Cholesterol levels and the side effects associated with them in human beings.
Cholesterol has been a major media issue in recent years, especially the negative effects on the heart and its role in the development of heart disease. There have been many studies that indicate a connection between serum cholesterol heart disease and depression (1-3). Developing new methods to lower serum cholesterol has become a major industry in recent years. Currently the leaders in the industry are American Pharmaceutical giants, Pfizer, Merck, and Warner-Lambert (1), who have developed medications that lower cholesterol.
The Endicon corporation recognizes the potential market in developing a drug that will significantly lower serum cholesterol without the side effects associated with long-term use of the drugs currently on the market. In addition, we recognize the potential of developing a British Product, primarily marketed in Great Britain. Endicon has been conducting research on a new drug that was recently developed by them and has been conducting preliminary studies on the efficacy and long-term effects of the new drug in laboratory animals. Results have been positive and it is now time to begin trials to test the efficacy and proper dosage needed to control serum cholesterol in human beings. The study will also examine any long-term side effects associated with the new drug. The market name of the new drug will be Cholestease.
Problem Statement
Currently there are several competitor drugs on the American market; however, they have yet to be approved for use in Great Britain. There are no current competitors in the British
Market that manufacture drugs for the purpose of lowering cholesterol. In addition, the drugs currently on the market in the United States are linked to serious side effects with prolonged usage (2). The Endicon Corporation has recently completed trials on a new drug that has conclusively lowered serum cholesterol levels in laboratory rats to normal levels within six weeks after beginning the medication. In addition, in longitudinal studies, prolonged usage of the new drug does not seem to have the serious side effects with drugs currently on the market.
With positive results indicating lower serum cholesterol levels in laboratory rats taking Cholestease and no serious side effects indicated, it is now time to begin preparation for human trials. The purpose of these trials will be to establish the most effective dosage of Cholestease in human beings, and to establish the most efficient dosage level. The most efficient dosage will be the one that has the most significant effect on lowering serum cholesterol, while at the same time, with the least amount of side effects.
Research Questions
The research questions to be answered in this study are exploratory in nature, rather than conclusive in nature. The primary purpose of this study is to determine the correct dosage of Cholestease in human beings. The proper dosage is not known at this time and this research will be designed as a preliminary step for further, more conclusive studies in preparation for marketing of the product. The first research question to be answered will be, "What is the most effective dosage for lowering serum cholesterol in human beings using Cholestease as a primary therapy?" The second research question will be, "What dosage of Cholestease has the fewest side effects?" The third research question will be the culmination of the first two research questions and will ask the question, "What dosage of Cholestease is the most effective at lowering serum cholesterol levels, while at the same time, having the least side effects. This will be used to determine proper clinical levels of the drug and determine administration guidelines for medical professionals once the drug is approved and marketed.
Rationale
The rationale for this study is based on previous studies that determined that high levels of cholesterol are a major contributing factor in heart disease. There...
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