Essentials Of Clinical Research Tampa Residents May Wish To Know
by Barbara Walker
Clinical research is needed to find cure for conditions that do not have a clear management protocol. It is also paramount that an alternative is provided to ensure that the conditions are put under control as cure is being sought. The aim of research is often to create a new drug, device or establish a non-pharmacological way of curing disease. There are several important concepts on <a href="www.clinicalresearchofbrandon.com/">clinical research tampa</a> residents may find interesting.
Before a drug is put on trial, it has to undergo certain processes to ensure it is safe for use in test subjects. Such processes will determine characteristic features of a potential drug including its absorption, distribution, metabolism and excretion from the body. This is referred to as the pharmacokinetics of the drug. Pre-clinical studies also try to find out the pharmacodynamic nature of the substance in question. Pharmacodynamics refer to the reaction of the body to the drug including its desired and adverse side effects. At the end of a pre-clinical study, researchers are in a position to decide just how much of the drug can be tolerated by a given individual.
In a situation where it is medical instruments under study, the above stage is skipped. Instead, the trial is taken through good laboratory practices. This stage depends on what the piece of equipment is intended for. In general, some devices are designed to help with diagnosis of disease while others are invented to replace a damaged vital part of the human system. A good example is the pacemaker device which is placed right at the center of the heart to keep it beating in rhythm. Before the device goes to the clinical phase, its effectiveness has to be ascertained.
Phase zero of clinical research is meant to speed up the trial process. It is, however, not considered a platform for testing the safety and toxicity profile of a drug. This is because very small concentrations of the agent are introduced in animal models. The exercise is usually done at a small scale. The ultimate goal is to rule out or rule in the possibility of the agent proceeding to the next stage.
Phase one of a study entails testing certain drug concepts on a given number of individuals. These concepts include formulation type, safety and dosing levels. Two to one hundred study subjects are utilized, on average.
Healthy individuals are the most suitable subjects for study. Unfortunately, these same individuals are bound to react negatively to the drug. Some money is usually offered to them to cater for any inconvenience caused. Terminally ill patients as well as patients unable to recover with already approved medication can join in the trial.
Phase two of research requires the participation of more than a hundred people. This phase mainly tests for efficacy of a drug on a larger number of individuals. The third phase calls for more than a hundred individuals to participate. It is an intensive phase that seeks to prove the value of a therapeutic agent.
The final step is phase four which is mainly a surveillance stage. This step can be used to study additional possibilities such as the effect of certain medication in pregnant women or children. Such special groups are usually hesitant to participate in the earlier stages because of the high risk involved and can only be included after successful tests in healthy adults.
You can get valuable tips for selecting a <a href="http://www.clinicalresearchofbrandon.com">clinical research Tampa</a> company and more information about a reputable company at http://www.clinicalresearchofbrandon.com now.
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