Activity: Pharmaceutical Company Scenario

Directions: Imagine that you are a senior executive for a large pharmaceutical company. You are responsible for the safety and effectiveness of the new drugs that your company introduces to the market.

The company is preparing to launch a new pain reliever. What sorts of effects would you examine in order to convince yourself (and regulators) that the drug is safe and effective? Remember to consider both acute and chronic effects!

  1. Select at least three biological responses that you would evaluate for your new drug. Choose any biological responses, harmful and beneficial, acute and chronic, that you think would be relevant to evaluating a pain reliever. Sketch your best guess of the dose/response curves for each response. The precise values of the median doses are not so important as your educated guesses about which will be lower and which will be higher.

  2. Which responses are acute? Which are chronic?

  3. What criteria would you use in order to call a new drug “safe”? (You might recall the concept of the Therapeutic Index.) What criteria would you use in order to call a new drug “effective”? (Are these criteria different for chronic, as opposed to acute, effects?) On the basis of your results, would you call your new drug "safe?"  Would you call it "effective?"

  4. Using your online collaborative tool, share your answers (including the dose/response curves) with your classmates. You might find these sharing suggestions to be helpful examples.

  5. Using your online collaborative tool, comment on at least one other student’s response to these questions.

    1. Are they measuring appropriate responses?

    2. Are they drawing the correct conclusions about safety and effectiveness?

    3. What did they think of that you did not?

  6. During your next class you will review some of your answers and discuss them together.