Before a medication can be sold in Canada, it must go through rigorous safety testing. When a sponsor (the person or company taking responsibility for the development of the medication, usually a pharmaceutical company) develops a new medication, it works with doctors and researchers to study its safety and effectiveness. Before a medication can be sold to the public, it has to go through several stages and many years' worth of rigorous testing for safety and effectiveness. On average, it takes 10 to 15 years to develop and test a new medication to ensure that it's safe and effective for people.
Here's how a medication's safety is evaluated and monitored.
Pre-clinical research
Pre-clinical research is the first stage in the medication testing process. This stage of research is performed in human cells in test tubes and in animals such as guinea pigs, rats, mice, and dogs. Pre-clinical research tests both effectiveness and safety. This stage takes between one and three years on average.
The goal of pre-clinical research is to thoroughly test the medication to see if it is safe and effective enough to be used in people. Pre-clinical research tests things such as how the medication works in the body, which doses may be effective, and whether the medication causes damage or unwanted side effects in any body areas. The standards for safety are so high that only 1 drug in 1000 actually makes it through this stage and goes on to be tested in people.
If the medication meets the rigorous safety standards set by the doctors and medical researchers from the sponsor, standards which are endorsed by the medical research community and approved by Health Canada, research moves on to the clinical trial stage.
Clinical trials
Clinical trials study the safety and effectiveness of the medication in people who have been informed of the potential risks and benefits and who have agreed to participate in the research. There are three phases to clinical trials:
Phase I: The medication is tested in healthy volunteers (usually 20 to100 people) to find out what doses of the medication you can give safely and to examine how the person's body processes the medication (how it is absorbed into the bloodstream and eliminated from the body).
Phase II: The medication is tested in people with the health condition it is intended to treat. Usually 100 to 300 people participate in phase II testing. This phase helps determine how well the medication works and how safe it is.
Phase III: The medication is tested in a larger group of people, usually 1000 to 3000 in total, who have the health condition it is intended to treat. The purpose of this phase is to further examine the safety and effectiveness of the medication in a larger group of people.
If the medication makes it though all these stages and meets the safety standards approved by Health Canada, the sponsor can submit the study results and other information for a Health Canada review to determine whether it can be sold in Canada.
If you have questions about how drugs are tested for safety, or are wondering how to get involved with a clinical research study, contact your doctor or pharmacist.
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