Answer each question Correctly
12 fonts – Times New Roman – Single Space
At least 1 page per question
NO PLAGIARISM
Paraphrase more, each and every single thing
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APA style Bibliography
Describe 5 differences between small molecule and biopharmaceutical manufacturing?
What biological impurities do you have to test for in biopharmaceutical manufacturing and why?
You have a highly lipophilic, small molecule, drug substance that has a moderately short half-life. What types of formulation changes could you make to improve bioavailability and lengthen half-life and why?
There was a recent report on weaponized ebola virus. How should the government prepare for the release of such an agent? Describe at least 4 specific tasks deployed either before or after the outbreak.
Describe the process for making a vaccine recombinantly. Describe the advantages and disadvantages of this approach versus using chicken eggs.
You want to develop an insulin pump that automatically regulates the quantity of delivered recombinant human insulin based on blood glucose levels determined by an accessory to the pump. What parameters will you need to measure in the clinical trials and what types of filings will you need to submit to the FDA?
You have received marketing approval for the insulin pump described in question 7. What marketing strategies would you implement to maximize consumer exposure and acceptance?
Describe the process for self-reporting an adverse event to the FDA. What information is required?
Describe a situation when an approved drug was pulled from the market permanently. What critical errors were minimized by the corporate sponsor as well as the FDA? Describe how these errors can be used to improve the NDA approval process.