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 next step is done in several phases, zero to four. Phase zero marks the start of testing in humans. A small number of people are recruited to take place in the study and are only given a small dose of the drug being tested. This helps avoid serious side effects which may not be known yet.
The next stage is phase one. This is only carried out if phase zero was successful. If the findings were unfavourable the options include making changes on the molecule or abandoning the study. This phase requires several months to be completed. It involves a slightly higher number of people who range from twenty to eighty. The main aim of this stage is to study the safety profile of the drug.
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 75 per cent of phase 1 studies usually proceed to the next step. At phase 2, the study participants are a few hundreds. The precondition for one to be considered as a participant is that they should have the medical condition behind controlled by the drug. There are several months of follow up by the researcher to see how effective the drug is in the larger. Data collected are used to make decisions on subsequent stages of study.
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 next step is done in several phases, zero to four. Phase zero marks the start of testing in humans. A small number of people are recruited to take place in the study and are only given a small dose of the drug being tested. This helps avoid serious side effects which may not be known yet.
The next stage is phase one. This is only carried out if phase zero was successful. If the findings were unfavourable the options include making changes on the molecule or abandoning the study. This phase requires several months to be completed. It involves a slightly higher number of people who range from twenty to eighty. The main aim of this stage is to study the safety profile of the drug.
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 75 per cent of phase 1 studies usually proceed to the next step. At phase 2, the study participants are a few hundreds. The precondition for one to be considered as a participant is that they should have the medical condition behind controlled by the drug. There are several months of follow up by the researcher to see how effective the drug is in the larger. Data collected are used to make decisions on subsequent stages of study.
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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Learn more about the clinical trials Brandon FL locals are talking about by visiting our official website now. To know more about our future treatments and our cause, click the links at http://www.clinicalresearchofbrandon.com today.
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