Question

Case Study

Instructions

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.

Answer 1

I will prefer to test that drug through computer simulation programs. Now a days we have technology through which we can determine the actual binding site of drug molecules in our body and can also mimic those sites through computer simulation.

Generally animal testing is being done in order to become sure about safety perspective of that drug. When animal testing is being passed then healthy volunteers are being chosen for testing purpose. In last stage, the drug is being given to patients to check it's efficiencies in real sense.

I am not in favour of animal testing and any such such type of testing. We can effectively utilise the miracles of biotechnology. We can use cell cultures. Now a days, organs can easily be grown in laboratory. We can test those drugs directly on these lab grown organs.

Side effects can also be measured in complete monitoring. If the drug is causing damage to lab grown cells then we can modify the composition. If it is not causing any damage then various environmental parameters can be changed and new effects can be noted down with full detailing.

This method provides full control over parameters and design of drug's composition. We can test again and again without being worried to get drug's leakage in surroundings. If same results are obtained in each and every test then only the drug can be given to a volunteer and to a patient in later stages.