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 clinical research tampa 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 some instances, medical equipment is usually the one undergoing scientific studies to facilitate diagnosis and treatment of disease. In this case, the device does not need to go through the initial pre-clinical phase as drugs do. Medical devices instead are taken through what is good laboratory practices with the aim of ascertaining whether the equipment is sustainable in the human body and just how safe it is for use.
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.
The next thing is to recruit a number of individuals ranging from three to a hundred. The main objective is to evaluate certain concerns including efficacy of a given dosage and the toxicity profile of the agent under study. Whether the agent will be in capsule, tablet or in solution form can also be determined at this point.
Individuals who are healthy are the preferred choice to be used for these studies. People living with advanced cancer are an alternative. Patients who have failed to respond to standard medication are also commonly enrolled in research programs. Ethical guidelines dictate that the individuals signing up for the research receive some financial help to offset any side effects that may occur.
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.
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 some instances, medical equipment is usually the one undergoing scientific studies to facilitate diagnosis and treatment of disease. In this case, the device does not need to go through the initial pre-clinical phase as drugs do. Medical devices instead are taken through what is good laboratory practices with the aim of ascertaining whether the equipment is sustainable in the human body and just how safe it is for use.
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.
The next thing is to recruit a number of individuals ranging from three to a hundred. The main objective is to evaluate certain concerns including efficacy of a given dosage and the toxicity profile of the agent under study. Whether the agent will be in capsule, tablet or in solution form can also be determined at this point.
Individuals who are healthy are the preferred choice to be used for these studies. People living with advanced cancer are an alternative. Patients who have failed to respond to standard medication are also commonly enrolled in research programs. Ethical guidelines dictate that the individuals signing up for the research receive some financial help to offset any side effects that may occur.
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.
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