PPD

PPD

 

Instructions: o Please submit in MS WORD . . o Your upper page limit is 5 pages, both sides, single-spaced, Times New Roman 12-point font; 1-inch margins (top/down and left/right). You have no lower limit as long as your answer is complete. No illustrations allowed. 1. You have been working at a pharmaceutical company for about two years and you are finally assigned a project of your own. Your company is developing a potentially groundbreaking drug for a disease that has no cure at the present. Your part of the project is to assess the risks of this compound in development.

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Instructions: o Please submit in MS WORD . . o Your upper page limit is 5 pages, both sides, single-spaced, Times New Roman 12-point font; 1-inch margins (top/down and left/right). You have no lower limit as long as your answer is complete. No illustrations allowed. 1. You have been working at a pharmaceutical company for about two years and you are finally assigned a project of your own. Your company is developing a potentially groundbreaking drug for a disease that has no cure at the present. Your part of the project is to assess the risks of this compound in development. Drug safety can be studied at various levels, for example, at the level of pre-clinical development. List and justify three additional levels at which drugs safety can be assessed. 2. List and explain three possible roles of a project manager. 3. List and explain three factors that can be explored by in clinical pharmacology. 4. For some mysterious reason, you chose to do your PhD in statistics. However, you still love pharmaceutical product development and got a job in the field. You were given a big dataset about a series of experiments using a new drug intended to alleviate the behavioral symptoms of autism. This was a double-blind study in a population of children with the condition. Half of the children received the drug. At first glance, the results seem to indicate that the drug improves certain autistic behaviors. Upon analyzing the results, you obtain a p-value of 0.093. ? What would be your null hypothesis? ? Are your results statistically significant? Why or why not? ? Based on the significance for the test you performed, what is the chance that you would be wrong if you reject the null hypothesis?