There is a huge number of diseases in the world today whose cure has not been found yet. This cure could be in form drugs, technology or even psychological. Even when definitive treatment is not established, scientists have to come up with ways of keeping a given disease under control. These are some of the basics of clinical research Tampa residents may find informative.
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.
A more recent step has been introduced to quicken the process of research. This step is simply referred to as phase zero. Only a limited number of individuals are tested. In addition, the drug administered is of levels way below the therapeutic concentration. The idea is to chaff out drug characters that have very minimal chances of being effective later in the trial and subsequently when launched into the market.
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.
Usually, healthy persons are used for study. The disadvantage is that these individuals may get sick in the process. Therefore, such people participate at a fee and informed consent is part of preparation. Alternatively, patients who are suffering from certain conditions and have not responded to all the available treatments in the market can sign up for such trials. Another category is that of patients with terminal illnesses.
In subsequent phases a greater number of participants is engaged. In most cases, more than a hundred people are scrutinized. Efficacy is the factor that is assessed at this point. Of note is that the third phase is usually the most tasking.
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.
A more recent step has been introduced to quicken the process of research. This step is simply referred to as phase zero. Only a limited number of individuals are tested. In addition, the drug administered is of levels way below the therapeutic concentration. The idea is to chaff out drug characters that have very minimal chances of being effective later in the trial and subsequently when launched into the market.
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.
Usually, healthy persons are used for study. The disadvantage is that these individuals may get sick in the process. Therefore, such people participate at a fee and informed consent is part of preparation. Alternatively, patients who are suffering from certain conditions and have not responded to all the available treatments in the market can sign up for such trials. Another category is that of patients with terminal illnesses.
In subsequent phases a greater number of participants is engaged. In most cases, more than a hundred people are scrutinized. Efficacy is the factor that is assessed at this point. Of note is that the third phase is usually the most tasking.
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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