Before a drug is approved for human use, it has to undergo several stages of development. This usually takes years and tremendous amounts of resources. A drug must pass all the safety measures and indeed, it must be effective. This process is what is commonly termed a clinical trial and comprises several steps. If they have plans of carrying out clinical trials Brandon fl researchers must understand all the stages involved beforehand.
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 stage comprises a number of phases the first of which is phase zero. Here, just a small group of subjects are included in the study. The number is often less than fifteen. At the same time, only a small dose of the drug under development is administered. This is mainly because the harmful effects, if any, may not be fully understood at this point.
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.
Apart from looking at the safety profile, phase 1 is also critical in determining the optimal dosage of a drug. A gradual increase in the dosage is done over time with the aim of establishing the highest possible dose that is not associated with serious side effects. Information relating to the best mode of administration is also obtained during this phase.
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 third phase is made up of a few thousand participants. They also have a medical condition targeted by the drug. The main role of this stage is to compare and contrast the effects of the new drug with those of pre-existing molecules used for the same condition. Participants receive either the existing drug or the new one in random fashion. The concept of double blinding is also employed to eliminate bias by the researchers and participants.
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 stage comprises a number of phases the first of which is phase zero. Here, just a small group of subjects are included in the study. The number is often less than fifteen. At the same time, only a small dose of the drug under development is administered. This is mainly because the harmful effects, if any, may not be fully understood at this point.
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.
Apart from looking at the safety profile, phase 1 is also critical in determining the optimal dosage of a drug. A gradual increase in the dosage is done over time with the aim of establishing the highest possible dose that is not associated with serious side effects. Information relating to the best mode of administration is also obtained during this phase.
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 third phase is made up of a few thousand participants. They also have a medical condition targeted by the drug. The main role of this stage is to compare and contrast the effects of the new drug with those of pre-existing molecules used for the same condition. Participants receive either the existing drug or the new one in random fashion. The concept of double blinding is also employed to eliminate bias by the researchers and participants.
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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