Recent studies support the potential of a drug that is derived from the metal ir
ID: 274407 • Letter: R
Question
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. What model(s) could be used 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 the choice. 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 determination. What information is gathered from the tests and whether or not the same protocol should be used for various categories of products such as drugs, cosmetics, and herbal medicines. Case study 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.
Explanation / Answer
Laboratory methods are usually followed to investigate the toxicity and safety of various drug candidate molecules routinely. In order to do so, appropriate cell/animal models are mandatory to be used. Use of computer simulations is required only in unique cases where the strucural integrity of the molecule is ambiguous. Hence, in order to investigate the safety and toxicity of the novel molecule, following models can be used:
Thus, depending upon the need of the experiment and the nature of molecule to be tested, appropriate combination of cell-models and small animal-models can be developed.
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