You are the Associate Director of a New Therapeutics research division in a Pharmaceutical Company called Ingenius Therapeutics. You have a lead product that has shown to bind very strongly to the Sodium Glucose Transporter 2 (SLGT2) and inhibit it’s function. It is known that SLGT2 helps reabsorb glucose from the urine and there are a couple of promising SLGT2 inhibitors already in Phase III clinical trials to treat type 2 diabetes. By inhibiting SLGT2, glucose is not re-absorbed from the urine and glucose levels drop.
Put together a project plan for your Director to explain how this drug will be tested, beginning with preclinical testing in vitro, through in vivo testing in animals and finally the steps you need to take to bring the drug to the marketplace. The project report must be less than 2,000 words.
Identify each stage of the testing.
Explain what models you are using to test the drug and why.
Describe the steps you need to take before you can begin human clinical trials.
Identify the results that you would need to achieve at each stage before you progress to the next step