Research in any field is done with an aim of inventing solutions for various situations based on the field of specialty. In clinical research, scientists work to come up with new and better methods of disease prevention and treatment. It also serves to provide temporary solutions to ensure that patients are kept comfortable while definitive treatment is in the process of being established. In this article we discuss details about clinical research Tampa residents may find meaningful.
As the term suggests, pre-clinical trials come right before the trial itself. The pre-clinical phase aims at establishing a safety framework for use of a drug among participants of the main trial. At this stage, important properties ( also known ad pharmacodynamics and pharmacokinetics) of a given drug are studied. Pharmacodynamics refer to the response of the body to the drug. Such will include, for example, the side effects and maximum safe dose. Pharmacokinetics, on the other hand, define how the drug is absorbed, distributed, metabolized and excreted from the body.
Trials may also be designed for testing medical devices rather than drugs. Medical devices are generally invented to enhance the accuracy of diagnosis of illnesses or to maintain functionality when an organ is or has failed. A good example is the artificial pacemaker. For such a device to be approved for use, researchers need to establish just how sustainable it would be for any given individual. Medical equipment and devices have to be taken through the stage of good lab practices to ascertain their safety.
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.
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.
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.
As the term suggests, pre-clinical trials come right before the trial itself. The pre-clinical phase aims at establishing a safety framework for use of a drug among participants of the main trial. At this stage, important properties ( also known ad pharmacodynamics and pharmacokinetics) of a given drug are studied. Pharmacodynamics refer to the response of the body to the drug. Such will include, for example, the side effects and maximum safe dose. Pharmacokinetics, on the other hand, define how the drug is absorbed, distributed, metabolized and excreted from the body.
Trials may also be designed for testing medical devices rather than drugs. Medical devices are generally invented to enhance the accuracy of diagnosis of illnesses or to maintain functionality when an organ is or has failed. A good example is the artificial pacemaker. For such a device to be approved for use, researchers need to establish just how sustainable it would be for any given individual. Medical equipment and devices have to be taken through the stage of good lab practices to ascertain their safety.
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.
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.
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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