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.
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.
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.
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 the trial is like the pre-clinical phase only that this time round human beings are used instead of animals. The number of subjects ranges from two to a hundred. This stage takes time to evaluate the dose that is needed to cause desired effect. It is at this stage that the best formulation is decided upon. Safety and toxicity is an additional concern.
Healthy individuals are the most suitable subjects for study. Unfortunately, these same individuals are bound to react negatively to the drug. Some money is usually offered to them to cater for any inconvenience caused. Terminally ill patients as well as patients unable to recover with already approved medication can join in the trial.
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.
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.
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.
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 the trial is like the pre-clinical phase only that this time round human beings are used instead of animals. The number of subjects ranges from two to a hundred. This stage takes time to evaluate the dose that is needed to cause desired effect. It is at this stage that the best formulation is decided upon. Safety and toxicity is an additional concern.
Healthy individuals are the most suitable subjects for study. Unfortunately, these same individuals are bound to react negatively to the drug. Some money is usually offered to them to cater for any inconvenience caused. Terminally ill patients as well as patients unable to recover with already approved medication can join in the trial.
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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