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New Medicine

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Please assist me with some research questions.
What does it take to bring a new medication to the market?
Should pharmaceutical companies have patents on their drugs? Why or why not?
How can pharmaceutical companies recoup the costs associated with failed drugs?
Explain examples of successful and unsuccessful pharmaceutical medications.
What happened with the unsuccessful ones?
Why were the successful ones successful?

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Solution Summary

The answer to this problem provides answers to issues of new medicine . The references related to the answer are also included.

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In compliance with BraiinMass rules this is not a hand in ready assignment but is only guidance.

To bring a new drug to the market, first preclinical testing is carried out. In this stage laboratory and animal studies are done to show biological activity and establish safety. After this stage, "investigational new drug application" is filed with the FDA and the drug is tested in people. Next Phase I Clinical trials are conducted in which the drug is tested on healthy volunteers. Phase II Clinical trials are conducted on patients for which the drug is to be used. Phase III Clinical Trials are large randomized trials which are given to the FDA to get approval of the drug. Next, the new drug application with all data from studies is filed with the FDA. Finally, Phase IV studies are conducted after marketing the drug from patients who are taking the drug.

Pharmaceutical companies ...

Solution provided by:
  • BSc , University of Calcutta
  • MBA, Eastern Institute for Integrated Learning in Management
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