How to New Medications Move from Inception to Market

Examination of the method by which a newly developed drug moves from inception to market.

After a drug has been developed in a laboratory, it must undergo many strictly controlled tests before it can be sold to the public at large. It can only be considered for human trials after it has been proven through preclinical trials that it can be beneficial.

If animal trials have yielded positive results for a drug, it must then be submitted to the IND (Investigational New Drug) and the FDA (Food and Drug Administration) before human trials can begin. Once they are sufficiently satisfied that the drug has potential and the levels of toxicity have been determined, they will be permitted to test the drug on humans.

During the first phase of clinical trials, safety and toxicity levels are investigated using human volunteers. At first, the drug is tested on a small group of volunteers — approximately 20 to 80 subjects. If the drug in question is thought to be extremely toxic, as is the case with certain cancer medications, it will then only be given to those who already suffer from the ailment.

The second phase of the trials will investigate the quantities of the drug that can be safely given to patients so that dosage levels can be determined. Approximately 100- 300 people will be involved in these trials, which can be conducted in several clinics and take place over a period of one to two years.

During the third phase, the drug is tested on a broader scale, involving 1000 – 3000 volunteers. The drug will be given to individuals who are afflicted with the disease and the outcomes will be compared with those of other existing drugs. Normally this phase lasts 2-4 years and provides the most useful results with regard to the drug and its effects. During the third phase, a control group of volunteers will be given a placebo. This is done to compare the effects that the drug has on those who have the disease but do not receive treatment.

If the drug is shown to be safe and effective, a new drug application is submitted to the FDA. Once the FDA approves the drug, it can be distributed. Every two years, the drug must undergo more safety tests. Once the results of the first 3 phases have been collected, the drug is approved and phase 4 begins. Phase 4 examines the general use of the drug and any side effects which may become apparent after an extended time of usage. The effectiveness of various forms of the drug will be investigated as well as how various dosage levels can affect its efficiency.

Once a drug is available on the market, it is continually tested and improvements are made for as long as it remains on the market. From the time a new drug is conceptualized until it reaches the market, it can take as long as 20 years. Millions of dollars are spent by the multi-billion dollar medical research industry to develop each drug in an effort to improve our health.

Update me when site is updated

Tags: , , ,

Comments are closed.