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BIOTECHNOLOGY - Essay Example

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Clinical trials is a method of clinical research, in which the researcher or researchers who directly observe a person or people, and/or who collect data to answer a scientific or medical question about the safety or benefit of an invention. The invention could be a medicine, a…
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BIOTECHNOLOGY
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Download file to see previous pages Clinical trials are more than efficacy and safety; they are designed to provide information about different types of outcomes of the invention. Studies relating to pharmaceutical product are carried out in clinical trials to reveal what does the product does to the body. Pharmacokinetics studies are also done to determine the proper dosing, which can vary according to race, sex and metabolic differences. Pharmacodynamic studies are also used to examine the ability, safety and the clinical activity of the drug or device. Thus, clinical trials are significant, since it examines the interventions in details before it hits the market to common man.
When the drug or any intervention is set for clinical trial, the experimentation stages are over. All the data regarding the invention are already been recorded, when it is set for clinical trial, it is to determine whether it can be utilized by humans or not. For example in case of any drug, the experiments relating to its origin, purification, its release etc, are already over when it hits the clinical trial. The study is also been carried in humans to determine the dosage, its side effects, after-effects etc. The safety and the effectiveness of the medication or device on a specific kind of patients are assessed. It is also assessed whether the new medication or device is more effective for the patient`s condition than the already used, standard medication or device. Thus, a clinical trail is not a set of experiments; it a set of both observational and interventional study.
3. What does safety really mean? [Hint: airplanes are relatively safe but every once in a while, an air plane will fall out of the sky. Does that mean we should ban airplane travel?? How is the safety of air travel any different than the safety of Vioxx or the safety of the drug-eluting stent?].
Drug safety has many implications on its use. In general practice ...Download file to see next pagesRead More
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