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.
Any trial is usually preceded by a feasibility study. The drug under development has to undergo several stages of laboratory tests before it can be used in human subjects. This is what is known as preclinical research. The idea here is to determine the effect of the molecule in question on human cells or animal models.
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.
If a drug shows serious side effects, the next phase cannot take off. The researcher has the option of modifying the molecule or giving up the study at this stage. Phase one is slightly larger than phase zero. The number of persons that are required at this point should be anywhere between 20 and 80. This stage is conducted over a couple of months with the main emphasis being on how safe the drug in question is.
Phase one is also important in several other respects other than side effect profiling. For instance, it is the period during which the effective dosage is determined. This is done by gradually increasing the amount administered to subjects and monitoring the side effects. The optimal dose is the highest that can be given without resulting in serious side effects. The route of administration can also be determined at this time.
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, four, is conducted after approval of the drug. Just a quarter of phase 3 trials get to this point, on average. The role of this stage is to conduct surveillance with the aim of documenting long term and rare side effects. Many years are required for the completion of this stage.
Any trial is usually preceded by a feasibility study. The drug under development has to undergo several stages of laboratory tests before it can be used in human subjects. This is what is known as preclinical research. The idea here is to determine the effect of the molecule in question on human cells or animal models.
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.
If a drug shows serious side effects, the next phase cannot take off. The researcher has the option of modifying the molecule or giving up the study at this stage. Phase one is slightly larger than phase zero. The number of persons that are required at this point should be anywhere between 20 and 80. This stage is conducted over a couple of months with the main emphasis being on how safe the drug in question is.
Phase one is also important in several other respects other than side effect profiling. For instance, it is the period during which the effective dosage is determined. This is done by gradually increasing the amount administered to subjects and monitoring the side effects. The optimal dose is the highest that can be given without resulting in serious side effects. The route of administration can also be determined at this time.
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, four, is conducted after approval of the drug. Just a quarter of phase 3 trials get to this point, on average. The role of this stage is to conduct surveillance with the aim of documenting long term and rare side effects. Many years are required for the completion of this stage.
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