What is needed for Drug ZL105, to be determined safe and effective for the treatment of cancer in humans?

Examine recent information on a key social issue in the U.S
December 14, 2017
The uses and limitations of the U.S. Food & Drug Administration’s (FDA) requirements on product labeling for public safety.
December 14, 2017

Unit VI Case Study
Recent studies support the potential of a drug that is derived from the metal iridium to effectively treat cancer. This experimental drug, Drug ZL105, has not been tested for efficacy and toxicity. Imagine that you are the one responsible for approving or denying the use of this drug within the United States. Your job is to propose the testing that is needed for this drug to be determined as safe and effective for the treatment of cancer in humans. In your research and discussion, you should address the questions below.

  1. What model(s) will you use for testing (i.e., animal, cell cultures, computer simulations)? Explain the choice of model, and provide support for the reliability of the model. Discuss the pros and cons of your choice.
  2. In determining the safety and effectiveness of the drug, would it be necessary to test efficacy, toxicity, and lethality? Explain what each of these tests are for and whether or not one or more of the tests are necessary for your determination.
  3. Provide your thoughts on what information you hope to gather from your tests and whether or not the same protocol should be used for various categories of products such as drugs, cosmetics, and herbal medicines.

Your case study assignment should be three to four pages in length and utilize at least three reliable references. Use APA style guidelines in writing this assignment, following APA rules for formatting, quoting, paraphrasing, citing, and referencing.
Information about accessing the grading rubric for this assignment is provided below.