What are the steps or stages within the nouns, trial, and approval of medical interventions.?
please leave some websites or something... thank you
Answers:
well in a clinical trial eg for a contemporary drug you go through 4 stages called phases. im sure its on wiki somewhere but in summary, you come up next to a hypothesis, eg this drug will increase serotonin levels or whatever, you then trial it on animals etc. then in phase 1 you test it on a small group of volunteer human patients. these are generally medical students by the way and the aim of phase 1 is to test the safety and determine the dosage which works for the drug. after in phase 2, you test the drug on a bigger group eg a few hundred patients. the aim at this point is to check for safety once again and also assess how okay it works. In phase 3 you try the drug on thousands of patients and the aim is to once again assess safet and this time to compare it against other treatment in the market since there is no point within releasing an effective drug if there is something out there within the market already which works quicker or has a better safety profile. Usually nearby must be 2 effective phase 3 trials for the drug to be approved. PHase 4 takes place after the drug is already available to be used by the general public and it is necessarily just a continuous phase of keeping an eye on the drug to make sure that there be no long-term problems associated with it that didnt show up in the original trials. the drug rofecoxib for example be excellent for the use of reducing inflammation in rheumatoid arthritis and had reached phase 4 and be being used rountinly by millions of people but was eventually after a while discovered to potentially affect the heart so be taken of the shelves. In all, it takes about 5-6 years until that time the drug even reaches the clinical phase period eg in making it and trialling it on animals and then the phases themselves can take up to 8-10 years.
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Answers:
well in a clinical trial eg for a contemporary drug you go through 4 stages called phases. im sure its on wiki somewhere but in summary, you come up next to a hypothesis, eg this drug will increase serotonin levels or whatever, you then trial it on animals etc. then in phase 1 you test it on a small group of volunteer human patients. these are generally medical students by the way and the aim of phase 1 is to test the safety and determine the dosage which works for the drug. after in phase 2, you test the drug on a bigger group eg a few hundred patients. the aim at this point is to check for safety once again and also assess how okay it works. In phase 3 you try the drug on thousands of patients and the aim is to once again assess safet and this time to compare it against other treatment in the market since there is no point within releasing an effective drug if there is something out there within the market already which works quicker or has a better safety profile. Usually nearby must be 2 effective phase 3 trials for the drug to be approved. PHase 4 takes place after the drug is already available to be used by the general public and it is necessarily just a continuous phase of keeping an eye on the drug to make sure that there be no long-term problems associated with it that didnt show up in the original trials. the drug rofecoxib for example be excellent for the use of reducing inflammation in rheumatoid arthritis and had reached phase 4 and be being used rountinly by millions of people but was eventually after a while discovered to potentially affect the heart so be taken of the shelves. In all, it takes about 5-6 years until that time the drug even reaches the clinical phase period eg in making it and trialling it on animals and then the phases themselves can take up to 8-10 years.
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