Outline the stages involved in research, development and testing of new pharmaceutical products

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1. Outline the stages involved in research, development and testing of new pharmaceutical products.  Within the outline include potential costs and a general time frame for the process.  


They have spent $12 billion for every drug they got approval for.

Discovery phase -4years

  1. The pharmacy will try to discover potential medicine. They will first identify the unmet medical need and the market opportunity, find a potential medicine through laboratory research, that is potent, selective and absorbed into and safe in the body. Begin the process of seeking patent protection for the potential medicine. The pharmacy will also collaborate with academia and external clinicians to access the best external science and medial opinion. These third parties may be involved throughout the medicine’s life-cycle.
  2. Safety and initial efficacy studies. Studies in the lab and in animals to determine if the potential medicine is safe to be introduce into humans and in what quantities. In this phase they start to understand the likely efficacy, side effects and maximum dose estimate in humans.
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Development phase – 7years

  1. Phase 1 studies – Studies typically in small groups of healthy human volunteers to understand how the potential medicine works in a human body, distributed around it and excreted. Study to determine a safe dosage and identify side effects takes place. They also begin to develop manufacturing route to ensure the manufacturing process is robust and costs are minimized.
  2. Phase 2 studies- Studies in small groups of patients to evaluate effectiveness of the medicine.
  3. Phase 3 studies- Studies in a larger group, looking at larger samples. They gather information about ...

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