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pharmaceutical product development – 2

by | Nov 30, 2023 | questions

hello, please make sure read and follow instructions… thanks…

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MS WORD document.
Minimum 1.5 pages for each question. single-spaced, Times New Roman 12-point font; 1-inch margins (top/down and left/right). No illustrations allowed.
Note : From last quiz.. he said this in class so make sure .. read this carefully… submission is compared to a database of documents from a wide variety if internet sources. Then the system gives me the % of the document identical to external sources. It is NOT acceptable to cut and paste text from other sources without attribution; that is plagiarism. In this year, for the first quiz the system gave me a range from 0% (great) to 7% (not so great).
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.
List and explain three possible roles of a project manager.
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…

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