Design a Trail for New Drug Term Paper

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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 are several non-drug approaches to lowering cholesterol including, lowering the dietary intake of cholesterol, reducing stress, and many other non-drug methods. These methods may be effective in controlling serum cholesterol in many cases. However, in many cases, they are often not enough due to the fact that the patient is unable to maintain the proper diet necessary or comply with other conditions that would help to lower cholesterol (4). In some cases a patient may be doing all of the right things to lower their cholesterol and still not able to maintain proper levels for an unknown reason. For these patients drug therapy may offer the best solution.

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This study is based on marketing research indicating a clear need for a drug on the British market that is effect in lowering serum cholesterol, while at the same time avoiding many of the serious side effects associated with other competitor drugs (3). There in an untouched British market in which no competition currently exists. In addition, there is also a chance to gain a significant marketshare away from competition in the United States once the drug is approved. This will be especially true if the drug is shown to be more effective and have lower side effects than its competitor drugs currently on the market. Preliminary market studies were conducted to determine, if in deed a market did exist for such a product in Great Britain. Based on these market studies is expected that sales will be significantly high, especially if the drug outperforms it competition in human trials.

Definitions

Cholesterol - a fat-like substance present in human beings and other animals. It is an important ingredient of cell membranes.

Dietary cholesterol intake - The average amount of Cholesterol consumed via the typical diet.

This is generally around 400 mg/day (Hudson, http://www.burnbraefarms.com/nutrition/cholesterolnews.pdf

High Density Lipoprotein (HDL) - This form of cholesterol is known as "good Cholesterol."

This form of cholesterol helps transport bad cholesterol to the liver for elimination. High levels of this cholesterol can help to prevent heart disease.

Low Density Cholesterol (LDL) - This form of cholesterol is known as "bad cholesterol." High levels of this type of cholesterol can lead to plaque in the arteries and eventually lead to heart disease.

Serum Cholesterol - A measure of the cholesterol levels, both HDL and LDL that are found in the blood. It is usually expressed separately as HDL and LDL cholesterol levels. It is the ratio between these two levels that helps to determine an individual's risk of heart disease due to high LDL.

Methodology

Sample Population

This study will be conducted using four test groups and one control group of patients. All participants in the study will be referred from endocrinologists and determined to have high cholesterol that has been uncontrollable by other non-drug means. The study will consist of 250 patients, with 50 patients in each category. All patients will be given a strict diet to follow for the duration of the test in order to control for any other factor, such as dietary cholesterol intake, that could skew the results of the test. The patients will be on an identical exercise schedule and will be considered to be at an average stress level. They will be of approximately the same weight and will not consist of any person considered to be obese, as this could skew the results as well. Demographic information will be collected and used as a means to eliminate biases due to demographic factors that may effect the results. Baseline cholesterol levels will be taken prior to the beginning of the trial.

Method

The control group will be on the same diet, exercise plan and from the same general sample population as the experimental groups and will serve to help detect any errors in the conduct of this survey. This group will act as a baseline by which to measure the cholesterol lowering effects of Cholesterease on the experimental groups. This group will also serve to identify any side effects or conditions that are not a result of the usage of Cholesterease.

The remainder of the sample population will be divided into for groups. The first group will be administered 5 mg of Cholesterease two times daily. The second group will be given 10 mg daily, the third group 15 mg daily and the fourth group will be given 20 groups daily. Each group will take half of the daily dosage two times a day. These levels were determined from a calculation based on the dosages that were proven to be effect on the laboratory rats.

The trial will run for six weeks. Each week the participants will be asked to get their cholesterol levels measured. This will help to determine if a particular dosage acts to lower cholesterol faster than other dosages. The results will be entered into a spreadsheet program and analyzed for significant difference in the performance of various dosages. If at any time a patient demonstrates adverse effects from the drug, they will be pulled from the study as indicated by their physician.

Data Analysis

Data will be analyzed using descriptive statistical techniques and….....

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