What are the stages of drug development process?
The process of bringing a medicine to the market takes up to 12 years, from initial discovery in the laboratory, through the phases of clinical testing to being licensed and available on the market.
Once a molecule is discovered, it undergoes extensive laboratory testing and experiments with animals in order to show its potential properties, safety and its value as a new therapy. The results from the pre-clinical phase are then submitted to regulatory authorities for approval to be tested on people in clinical trials.
The clinical trials stage consists of three main phases and all new medicines have to go through these parts before they can be prescribed to patients. The clinical phase is there to establish the dose and best form of the drug, its safety, how it is absorbed by the body and furthermore whether the treatment works. The main phases of clinical research are:
Phase 1: trials are often the first time a drug is administered to humans and usually involve a small number of volunteers. These often focus on healthy individuals, who are given compensation for their participation. Phase 1 is mainly about understanding whether the drug is safe to use in humans, rather than how effective it may be at treating a specific disease. This is when the optimal dose is established, and side effects are assessed.
Phase 2: trials involve patients and the number of participants is higher than in the previous stage. This stage aims to assess how well the drug works at treating a particular disease and the more about the best method for delivery e.g. tablets, sprays, injections etc. Many treatments do not make it to Phase 2.
Phase 3: trials require much larger groups of patients, from hundreds to thousands; and they aim to compare the effects of the new drug to either a placebo or a standard treatment.
Once these stages of clinical research prove the effectiveness of the investigated drug, the treatment can be approved and registered with the country’s regulatory authority as a new therapy for patients. The final, post-marketing stage of drug development involves research on long-term benefits, side effect and drug’s optimal use.
As an early drug development company, Quotient Clinical performs Phase 1 clinical trials as well as supporting patient studies by supplying drug product to specialist clinics.
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Journal of Developing Drugs