Unit VI Case Study
BOS 4201 Toxicology
Columbia Southern University
Unit VI Case Study
There have been recent studies conducted that have shown support for the potential of an experimental drug, ZL 105, that is derived from the metal iridium and is effective at treating cancer. Current treatment methods that are being used are becoming less effective after first runs, as the cancer learns how it is being attacked and, in some instances, cause far too many side effects that cause damage to healthy cells (ScienceDaily, 2014). Before this new drug can be used in human testing or trails it must first be subjected to more tests to identify its efficacy, toxicity, and lethality. Without conducting tests to further determine the safety and effectiveness that this drug can have would be counterproductive and could potentially lead to more harm than good.
There are several research testing methods that could be used to identify ZL 105s efficacy, toxicity, and lethality such as animal testing, cell cultures, and computer simulations. Both animal and non-animal research is used to study the potential health problems of the world around us (Society of Toxicology, 2006). For ZL 105 research to be the most effective there should be a combination of testing models used to include limited animal testing, organs-on-a-chip, and computer simulations. The reasoning behind choosing to use multiple models is multipurposed. All three of the chosen methods have pros and cons associated with them, the thought of using multiple methods is to capitalize on the pros of each method while minimizing the cons. Utilizing multiple methods gives various data points to pull from, and validate the information gained or show that the ZL 105 is not what it was thought to be and denied usage. This will enhance the overall reliability of the research conducted.
Animal testing has been utilized for research purposes since the time of Aristotle and Erasistratus and we have decades of research to potentially pull from, but is considered a cruel and inhumane method to use. To date it is the most reliable and accurate model for testing new drugs. One pro for this method is being able to see how ZL 105 will affect a whole system. Additionally, in absence of human data, research with experimental animals is the most reliable means of detecting important toxic properties of chemical substances and for estimating risks to human and environmental health (Richards & Bourgeois, 2014). The 3 Rs strategy will need to be applied with this method, which stands for reduction, refinement, and replacement of laboratory use of animals. Downfalls to using this method are it is expensive, time consuming and as stated previously controversial.
The next method of use will be the Miniature Organs or organs-on-a-chip. This method utilized cultured human cells on a scaffold embedded on plastic chips that form structures that can mimic specific organs (Bryce, 2019). The pros of this method are being able to see how ZL 105 will interact with human cells without harming humans. The organs-on-a-chip method will also cut down on the number of animals used in the previous method. A con to this method is researchers won’t be able to see the effects on a whole system.
The third method that will be utilized will be computer simulations. The data from the years of animal research can be taken into account without further animals tested and used to the benefit of ZL 105 testing. Additionally, by using computer simulations researchers can cut down on expenses and the time it takes to validated effectiveness due to the advances in this field. A down fall to using computer simulations is that it can only calculate on previously known information, so if there are any unknowns they cannot be simulated unless there is a theory on how it should work.
To determine the safety and effectiveness of ZL 105 it will be necessary to test for the drug’s lethality, toxicity, and efficacy. Gaining the knowledge of these three previously mentioned effects is essential to preventing further harm to those with cancer. It would be foolish indeed to release a drug without fully knowing the dangers or potential side effects it can cause. If done it would cause more harm than good and that is not the point of a cure. All the data gained from the research conducted will help in establishing the efficacy, toxicity, and lethality of ZL 105.
Efficacy, of a drug is the level of benefit one will receive from utilizing said drug toxicity informs us at what levels the drug has the potential to be toxic and lethality tells us at what dosage the drug can be fatal. By completing a test for efficacy researchers can make a reasonable determination on the benefits of ZL 105. In addition to efficacy, toxicity and lethality need to be tested to ensure the proper dosage to use to prevent harm. Multiple tests will need to be run to ensure enough data is collected accurately determine if ZL 105 will be effective of not. If positive results return ZL 105 can be activated for use, if negative results come back then researchers can make the determination to halt further testing.
From an individual standpoint of having to make a determination on the safety and effectiveness on ZL 105 for treatment of cancer in humans the collection of as much data as possible is needed. The ultimate goal is to prove or disprove the positive effects ZL 105 will have battling cancer, with this in mind researcher will need to be a through and unbiased as possible, taking shortcuts in this would be a horrific idea. To achieve this multiple test will have to be ran with multiple methods utilized. This will give the most information on how ZL 105 interacts with cancer and humans. Additionally, it will give us enough data to make a determination of whether this drug is the miracle it is thought to be or if other avenues need to be taken fighting cancer. The results of these tests will inform us to the efficacy, toxicity and lethality which is the point of if this drug is safe for use or not. Even outside the realm of testing for cancer drugs such as cosmetics and herbal medicines this same protocol should be adhered to, doing so will ensure the safety of the product to the consumer. The point of testing any type of product be it a cancer drug such as ZL 105 or an herbal medicine is to prevent more harm from happening than good to the end user. Thus, all products should be tested as effectively as ZL 105.
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