Testing A Drug Before Release
Advancements in the pharmaceutical industry have come a very long way in the last hundred years. Still, drugs can cause dangerous side effects and even death if not prescribed properly. Before drug development services can put a drug on the market, they must follow certain procedures to endure safety.
Four Phases of Clinical Trials
Drug development is heavily monitored by the Food and Drug Administration (FDA) to ensure the drug is safe for the people who take it. The FDA has set up a system of four phases that a drug must go through when it is tested on humans before it can be released to the public.
- Phase I- In the first phase, the drug is administered to a small group of people (10 - 80). The point of this phase is to prove that the drug is safe, identify side effects, and determine dosage.
- Phase II- In the phase, the drug is brought to a larger test population (100 - 300 people).
- Phase III- In the third phase, the test size grows to 1,000 - 3,000 people. At this time, the drug must be compared with other treatments. The drug's side effects will continue to be monitored to assess the pros and cons of taking the drug. This is typically the longest phase and will be conducted by a number of different researchers at different facilities to ensure consistency.
- Phase IV- In the final phase, the drug is on the market. This phase is to monitor any side-effects that might appear after an extended period of time.
Types of Trials
So how do researchers complete the trials in these four stages? Generally speaking, the researchers will use one of the following methods to complete their research:
- double-blind study- In a double-blind study, there are two groups of participants. One group (the control group) receives the medication. The second group receives a placebo- a pill or injection that looks like the medication but without any of the medicine in it. Neither group knows which is taking the actual medication and which is taking the placebo. The researchers don't know, either. This offers less bias and consequently more accurate results.
- open-label studies- Open-label studies allow the participants to know what drug they are taking. The researcher also knows. This allows more of an opportunity for bias, but it can be safer if the drug being tested is particularly strong.
Contact a company like Drug Development Consultants for more information and assistance.