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.
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.
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.
In a bid to hasten the research process, an initial step commonly referred to as phase zero was recently put in place. At this stage, the testing is usually done in animals. Moreover, very minute doses are administered. At the end of day, researchers can deduce which drug is promising enough to continue in the trial process.
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.
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 fourth and final phase emphasizes on getting the finer details. For instance, certain groups of people that may not have been evaluated in at the preliminary level fit in perfectly at this stage. Expectant women and infants are classic examples.
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.
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.
In a bid to hasten the research process, an initial step commonly referred to as phase zero was recently put in place. At this stage, the testing is usually done in animals. Moreover, very minute doses are administered. At the end of day, researchers can deduce which drug is promising enough to continue in the trial process.
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.
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 fourth and final phase emphasizes on getting the finer details. For instance, certain groups of people that may not have been evaluated in at the preliminary level fit in perfectly at this stage. Expectant women and infants are classic examples.
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