How Does A New Drug Reach The Market?
We all take medicinal drugs for granted, we walk into the pharmacy, hand over our prescription and within minutes the drug is sitting in our medicine cabinet. What we don’t realise is how long it actually takes for the development of that drug and what is involved.
Only five in five thousand drugs actually reach preclinical testing and it can cost well over £500,000 per drug. From that only one in five will ever reach your medicine cabinet.
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The development of drugs is broken down into three main stages, the identification stage, the clinical stage and then the approval stage.
Many drugs we know today were actually accidental findings, such as Penicillin. This has changed and today there are researchers and scientists around the world that dedicate themselves to finding cures for various diseases.
The first stage to any new drug that reaches the market is the identification stage where scientists work to develop a compound that can be used to treat a specific disease. These compounds are then analysed to determine their success rate before heading to any preclinical trials.
The scientists also need to determine during this stage the best way to administer this new drug. Are powder filled capsules, tablets, liquids or sprays the best way to administer the drug and offer the best overall effect?
Preclinical trials are carried out which means testing the drug in the laboratory and on animals, it usually takes just over three years of constant research to complete this stage .
Human Testing and Clinical Trials
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Once the initial research has been carried out the drug company will request the ability to test on humans. Reports cover any experiments carried out so far and the results to help the authorities make the right decision.
Once this stage has been approved the first phase of clinical trials can begin. This is where the drug is tested on healthy volunteers; this is done to determine the drug’s safety, how it is absorbed by the body and what dosages should be used. This phase usually takes around one year to complete.
From there it moves on to the second phase of clinical trials where the drug is then tested on volunteers who have the disease the scientists are trying to cure. It is during this stage that the maximum dose can be determined and how it affects the patients. This trial normally lasts a further two years.
Eventually the drug moves into the third phase of clinical trials, this is where the drug is tested for safety and effectiveness. A large number of volunteers, often thousands, take part in these trials which are held at hospitals and clinics around the world. They are asked to advise on any side effects they may experience during the trial which normally lasts around three years.
Once all the testing has been completed the company applies for the drug to become available to the public. In the US they need a NDA (New Drug Application) form completed and approved and in the UK they submit a MAA (Marketing Authorisation Application) which needs to be approved.
With the application the company supplies a detailed report which details all the data collected and the results of the trials carried out, these reports are usually well over one hundred thousand pages long and offer the authorities all the information they need to make the decision. In some cases these decisions can take years to make and become final.
You would think it would all be complete by now, but even after approval studies are still carried out and further data is collected from patients using the drug to determine any further side effects which may be experienced.
This article was by Cancer Research UK who provide help with living with breast cancer.