Life Cycle Of A Drug
Once a new drug has been developed in a laboratory in must then pass through a number of tightly controlled tests before it can be made available to the general public. Only after proving that it has the potential to benefit medicine through demonstration of its abilities in preclinical trials, can it be considered for human trials.
If a drug has shown positive results in animal trials it then needs to be submitted to the IND (Investigational New Drug) and the FDA (Food and Drug Administration) before it is given permission to be used in human trials. Once they are satisfied that the drug shows potential and that the toxicity levels have been determined, they will allow it to be used on human subjects.
Phase 1 of clinical trials is concerned with investigating the safety and toxicity levels of the new drug on human volunteers. The drug is initially tested on a small group of volunteers consisting of 20 - 80 people. If the drug in question is considered to be highly toxic such as certain cancer medications, then it will be administered only to those who already have the disease.
Phase 2 of the trials will investigate how much of the drug can safely be administered to patients and will determine the correct dosage level. These trials will involve a group of around 100 - 300 people and the trials can be conducted in a number of clinics over one to two years.
Phase 3 will see the drug tested on a much larger scale and will involve tests on 1000 - 3000 volunteers. The drug will be given to those who are suffering from the disease and the results will be compared with other drugs already available. This phase will typically last between 2- 4 years and gives the most useful results as to the nature of the drug. During phase 3, researchers will also use a control group of volunteers who will be administered a placebo. This is to compare the effects of the drug in those that have the disease but do not receive treatment.
If the drug proves to be safe and effective a new drug application is submitted to the FDA for approval and can then be distributed. The drug must undergo additional studies for safety every two years. Phase 4 begins after the results of the first 3 phases have been collected and the drug is approved. Phase 4 studies the general use of the drug and any side effects that may become evident after long term use. It will also investigate the effectiveness of different forms of the drug and how various dosage levels can alter its efficiency.
Once a drug is released into the market it is continually tested and improved upon as long as it is in circulation. It can take up to 20 years for a new drug to reach the marketing stages from when it was first theorized in a laboratory. Medical research is a multi-billion dollar industry and millions are spent on each individual drug in the quest to improve our health.
This obviously has an effect on the sale price of these drugs. To cut the costs you need to have a solid health insurance that can cover the main costs. A lot of insurance companies give you the opportunity to request a free health insurance quote, so take your chance!