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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.
Pre-clinical trials precede clinical trials in order to confirm the safety profile of a given agent before it is tried on a human being for studies. The main goal of the pre-clinical study is to come up with the appropriate dose that can be given without harming the subject under study. It includes both pharmacokinetics and pharmacodynamics. The former determines how a drug behaves in the body, right from absorption and distribution to the time it is metabolized and excreted from the body. The latter describes the response of the agent by the human system.
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.
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.
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.
Last but not least is the fourth phase which aims to refine the research to assess special areas such as drug interactions involving the new molecule. It also assesses pregnant women and the young age group. This is attributed to the fact that these fall in the bracket of extremely high risk groups.
Pre-clinical trials precede clinical trials in order to confirm the safety profile of a given agent before it is tried on a human being for studies. The main goal of the pre-clinical study is to come up with the appropriate dose that can be given without harming the subject under study. It includes both pharmacokinetics and pharmacodynamics. The former determines how a drug behaves in the body, right from absorption and distribution to the time it is metabolized and excreted from the body. The latter describes the response of the agent by the human system.
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.
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.
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.
Last but not least is the fourth phase which aims to refine the research to assess special areas such as drug interactions involving the new molecule. It also assesses pregnant women and the young age group. This is attributed to the fact that these fall in the bracket of extremely high risk groups.
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