Advertisement

What is the life cycle of drug safety monitoring?

Drug safety monitoring is an ongoing process that begins long before a product enters the marketplace and continues long after it has been made available to patients.

In pre-clinical trials, laboratory experiments determine if a compound is a potential medicine. These are followed by clinical trials, a series of studies (phases I, II, and III) to determine if the drug is safe and effective in patients. Once a drug application is received by the FDA, the FDA examines the safety and efficacy data and may request additional studies. If the drug is approved the medicine is made available to patients. At that point, long-term safety monitoring begins in what are known as phase IIIB and phase IV studies.

Continue Learning about Drug Safety

How Much Ibuprofen Is Too Much?
How Much Ibuprofen Is Too Much?
Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen are some of the most commonly used medications, with more than 30 billion doses taken ann...
Read More
What is the FDA's role in drug safety?
PhRMAPhRMA
The FDA serves as a consumer watchdog—it makes sure that safe and effective drugs are available to i...
More Answers
So, how does inkjet technology figure into drug patches?
Discovery HealthDiscovery Health
In the drug patch using inkjet technology, the flow of drugs is controlled in the same way as the fl...
More Answers
What Should I Discuss With My Doctor About My Heart Medications?
What Should I Discuss With My Doctor About My Heart Medications?

Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.