What were the top three drugs determined to be effective in
What were the top three drugs determined to be effective in
Correctly answer each and every questions/single thing…12 fonts – Times new roman – Single space…Total Minimum/At least 5500-6000 words…Be Specific – Qualitative and QuantitativeNO PLAGIARIUSM – NO COPIED WORK…Paraphrase more, each and every single thingIt will be checked by Turnitin SoftwareNo Spelling / Grammar MistakesAPA style BibliographyDue Dec – 07, Saturday Evening1. For one of the drugs approvals or rejections in 2013, discuss the results of the FDA advisory committee meeting, the initial FDA response to the NDA, the company’s response to the FDA, the effect on the company’s stock price, and any additional action taken by the FDA based on further data that was supplied.2. In the German report on health outcomes of antidepressants,https://www.iqwig.de/download/G09-01_Executive-summary-of-final-report_Health-economic-evaluation-of-venlafaxine-duloxetine-bupropion-mirtazapine.pdf, answer the following:a. What were the top three drugs determined to be effective in chronic depression?b. Which were determined to be most effective in head-to-head competition?c. Which were determined to have the most adverse events leading to discontinuation?d. Which were determined to lead to a higher quality of life?e. We’re the most effective drugs priced the highest?f. What were the 3 highest cost factors in the continuous treatment of depression?g. Was there a recommendation for the most appropriate treatment? If so, what was it?h. Should the US government and insurance companies here use a similar approach? Why or why not?3. For one of the drugs that was approved in 2013, find one where there was a licensing deal, co-marketing agreement, or a company buyout during the development of the drug. Find out the original discovering institution, at what point in the development cycle the transactions occurred and what were the financial considerations. Find the yearly price of the drug and comment on whether there is any competition for its indication and if so, the cost of the competitor’s drug.4. For one stage in the development cycle, choose a task that will be completed by a contract research organization. State under what conditions this strategy makes sense. Find out how long this task will take, what will be the expected outcomes and what is the average price for such a service. Under what circumstances would this strategy not make sense? What are the ramifications for both the CRO and the contracting company for unexpected outcomes and delays? What are some additional costs and time frames for likely delays?
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