The process of developing new drugs and other forms of treatment if often a long and tedious one and requires huge financial resources. Pioneer drugs are often subjected to a vigorous testing process known as a clinical trial before they are approved for use in the general population. If they intend on carrying out clinical trials Brandon fl residents need to understand a number of things on the procedure involved.
This process of testing is usually preceded by what is termed preclinical research. At this stage the new molecules or methods of intervention are tested on animal models, human cells or tissues in a laboratory. This step determines whether the trial will proceed or will be abandoned. For instance, if a new drug is found to be toxic to animal models, there is a very high likelihood that it will be harmful to human tissues as well hence, there is no need to proceed.
The clinical research proper starts with phase zero. This is the first point at which a drug is given to human subjects. The number of people is usually small (about 15) and the dose of the drug is also quite low. This is to avoid unwanted effects that may not be known yet. It takes a few months to complete.
A successful phase zero allows for the commencement of phase 1. If unwanted effects are noted, however, more research at the preclinical stage is warranted. Phase 1 is typically carried out over several months. The main objective is to determine the effects of the drug (or any other intervention) on the test subjects. The number of people enrolled here ranges from 20 and 80.
Phase 1 provides the researcher with other important information other than the side effects associated with the drug. Part of this will include the optimum dose that can be used. This is determined by a gradual increase of the dose to the maximum level that can be tolerated. It is also possible to know the most effective route of administration.
About three quarters of phase one trials proceed to phase 2.The number of subjects is in the hundreds at this point. The usually have the disease or medical condition for which the drug is being developed. Participants will usually be followed up over several months to a few years. Data from this phase are used to determine how the next phase is to be carried out.
The participants enrolled at the third phase are usually several thousands. They too are required to be suffering from the condition for which the drug has been designed. At this stage, the researcher will compare the profile of the new drug with those of other drugs that have been in the market. Participants may receive either the older or the new drug through a randomized allocation system. The results of each drug are then analyzed.
The final phase, 4, takes place after a drug has been approved for human use. About a quarter to a third of studies from the third stage, make it to the fourth. Thousands of participants in a vast geographical area are involved. The idea is to monitor long term side effects of the drug since these may not be evident in the earlier stages.
This process of testing is usually preceded by what is termed preclinical research. At this stage the new molecules or methods of intervention are tested on animal models, human cells or tissues in a laboratory. This step determines whether the trial will proceed or will be abandoned. For instance, if a new drug is found to be toxic to animal models, there is a very high likelihood that it will be harmful to human tissues as well hence, there is no need to proceed.
The clinical research proper starts with phase zero. This is the first point at which a drug is given to human subjects. The number of people is usually small (about 15) and the dose of the drug is also quite low. This is to avoid unwanted effects that may not be known yet. It takes a few months to complete.
A successful phase zero allows for the commencement of phase 1. If unwanted effects are noted, however, more research at the preclinical stage is warranted. Phase 1 is typically carried out over several months. The main objective is to determine the effects of the drug (or any other intervention) on the test subjects. The number of people enrolled here ranges from 20 and 80.
Phase 1 provides the researcher with other important information other than the side effects associated with the drug. Part of this will include the optimum dose that can be used. This is determined by a gradual increase of the dose to the maximum level that can be tolerated. It is also possible to know the most effective route of administration.
About three quarters of phase one trials proceed to phase 2.The number of subjects is in the hundreds at this point. The usually have the disease or medical condition for which the drug is being developed. Participants will usually be followed up over several months to a few years. Data from this phase are used to determine how the next phase is to be carried out.
The participants enrolled at the third phase are usually several thousands. They too are required to be suffering from the condition for which the drug has been designed. At this stage, the researcher will compare the profile of the new drug with those of other drugs that have been in the market. Participants may receive either the older or the new drug through a randomized allocation system. The results of each drug are then analyzed.
The final phase, 4, takes place after a drug has been approved for human use. About a quarter to a third of studies from the third stage, make it to the fourth. Thousands of participants in a vast geographical area are involved. The idea is to monitor long term side effects of the drug since these may not be evident in the earlier stages.
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