Q1) Humana laboratories have produced a new human insulin. They would like to determine if their insulin is as good as Humulin (an already marketed human insulin).Please conduct a study to determine if these insulin are equivalent from the pharmacokinetic and pharmacodynamic point of view.Provide the last expensive and less time-consuming study design. Provide graphs and/or tables of the results.
Q2) Design a study to investigate if the use of ibuprofen is responsible for the increased incidence of Acne. Use the most efficient study design. What results would you expect if ibuprofen is not effective? Simulate data. Discuss number of patients, and other variables that you may consider have interest in order to match the groups.
Q3) The FDA requested that you design a study to determine if Atenolol is effective in the Prevention of Vasovagal Syncope in subjects older than 60 years of age.
Background:Syncope is a very frequent disabling condition. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. The median number of faints in a year is 6. There is no known medical treatment for frequent fainting. However 3 observational studies suggested that beta blockers prevent syncope in older subjects.
Describe in detail the study design that best answers the research question.
Include how you would take care of all steps of the research design you proposed?
Would you include a comparison group?
Duration of the study?
Interim analysis: yes or no and why?
Expected results if atenolol resulted effective? Simulate data in a tabular form, and discuss best statistical test to determine if the results were statistically significant
0 comments