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Case Study

Instructions

Recent studies support the potential of a drug that is derivedfrom the metal iridium to effectively treat cancer. Thisexperimental drug, Drug ZL105, has not been tested for efficacy andtoxicity. Imagine that you are the one responsible for approving ordenying the use of this drug within the United States. Your job isto propose the testing that is needed for this drug to bedetermined as safe and effective for the treatment of cancer inhumans. In your research and discussion, you should address thequestions below.

1. What model(s) will you use for testing (i.e., animal, cellcultures, computer simulations)? Explain the choice of model, andprovide support for the reliability of the model. Discuss the prosand cons of your choice.
2. In determining the safety and effectiveness of the drug, wouldit be necessary to test efficacy, toxicity, and lethality? Explainwhat each of these tests are for and whether or not one or more ofthe tests are necessary for your determination.
3. Provide your thoughts on what information you hope to gatherfrom your tests and whether or not the same protocol should be usedfor various categories of products such as drugs, cosmetics, andherbal medicines.

Your case study assignment should be three to four pages inlength and utilize at least three reliable references. Use APAstyle guidelines in writing this assignment, following APA rulesfor formatting, quoting, paraphrasing, citing, and referencing.