In the United States the development of a new drug, for human consumption is a long and difficult process requiring many levels of testing. Mandated by the food and drug administration (FDA) the rigorous process of new drug development can consists of at least four phases. If the FDA approves the new drug to be safe and effective for humans, generally, from start to finish the entire process of new drug development, take an average of 12 years of experimental research costing the pharmaceutical company millions of dollars.
Recently a pharmaceutical company wants to test a new sleep aid for humans, using a scenario like this can provide more specificity on exactly how the potentially new sleep aid goes from the laboratory to a consumer. In new drug development, researchers systematically use the experimental research placing emphasis on key elements–hypothesis, randomization, treatment group, control group, and measurement (University of Phoenix, Week Three Supplement, 2012).
Each key element of experimental research corresponds to a specific phase in new drug development. Possibly the most important element is hypothesis testing that occurs in the pre-clinical research phases of new drug development. Hypothesis testing in the pre-clinical phase is necessary to support the claim made by the pharmaceutical to convince the FDA that the new sleep aid shows is effective and safe to test on humans (Simonoff, 2010).
The Research paper on Animals And Certain Disabled Human Animal Testing Man
Injections OR Protection Although testing on animals seems the only way to further advance our medicine, technologies, and prevent products from harming people, it doesn't necessarily make it right. I think we can all agree that injecting defenseless animals with dangerous chemicals resulting in serious side effects or possible death is cruel and unusual. Coincidently, in the U. S. we consider ...
In this case, the hypothesis is that the new sleep aid is more effective in reducing the symptoms of insomnia.
Using evidentiary support in pre-clinical trials of the new sleep aid did prove the claim of efficacy and that it is safe to test on humans in clinical trials. The next step in new drug development occur in three phases of clinical trials in which researcher’s further use experimentation to test the hypothesis of the sleep aide on human subjects. Critical to clinical researchers/scientists is to reduce confounding factors (health, age, culture, gender, and race) as this can affect the results of the experiment (Myers, 2012).
Therefore, clinical scientist or researchers randomly assign the human subjects to a treatment group, or control group. The treatment group exposes the independent variable to the subjects whereas the subjects in the control group do not have exposure to the independent variable (Comer, 2012).
By comparing the treatment and control groups, the experimenter can better determine the effect of the independent variable— or measure the variable that indicates if the hypothesis is true or not (Comer, 2012).
Therefore, in terms of measurement — the independent variable to measure is the new sleep aid in which experimenters did expose to participants in the treatment group with symptoms of insomnia. Proving effective, in terms of the time it takes for one to fall and stay asleep the experimenters might consider the new sleep aid or independent variable as therapy, or a way of treatment for participants with symptoms of insomnia.
Furthermore, the clinical scientists, researchers, and or experimenters consider the dependent variable the medical or psychological improvement caused by the independent variable. Clinical trial phases in new drug testing lasts up to three years in which the new sleep aid continues further testing on thousands of existing patients (who volunteer) in clinics and or hospitals (Today’s Science, 1995).
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AIDS caused by HIV infections through the transmission of human body liquids. It is recognized now as the most lethal virus among the world. There s no exact cure for it; drugs (medical treatments), physiotherapy, and the recent developed "Cocktail Treatment" seem to be the choices that a patient can relay on. Even though there is reports that people with HIV infected are being denied medical or ...
If perhaps, the new sleep aid meets FDA approval, this may occur at least ten to twelve years later– after which experiments will continue to determine if there are long-term side effects of the new aid.
It is evident that in the United States, new drug development is a long, costly process including but not limited to hypothesis testing, pre-clinical, clinical trials, thousands of brave subjects in treatment and control groups (and more).
In the hope to provide safe, effecting drug treatment to help in the treatment of illness and disease in human and animals– dedicated scientists, various specialists, and researchers press on– using the key elements of experimental research to do so.
