Before a drug is put on the market, tests must be set up to guarantee the efficiency of the doses administered. Several patients may be tested to demonstrate the effectiveness of the new drug. Obviously, pharmacological activities involve a series of tests.
WHAT ARE THE DIFFERENT STEPS OF A DRUG TEST?
Before being sold on the market, each drug must be tested to ensure its efficiency and to understand its possible effects. The drug test may involve several trials. A priori, it is important to have a knowledge of the phase 1 trial. This is a preliminary evaluation of the efficacy of the drug through a relatively low dose. The test can highlight the fusion of two drugs. The scientific study induces the obligation to pass a phase 1 trial followed by a phase 2. The second part aims at confirming the clinical activity highlighting the recommended drug dose. The test will be carried out with patients to demonstrate the quality of the treatment. It should be noted that phase 2 can take up to 3 years.
WHAT SHOULD I REMEMBER ABOUT THE PROCESS OF A DRUG TRIAL?
The phase 2 trial will show different effects depending on the patient’s pathology. Thereafter, the drug must show comparative trials to constitute phase 3. The objective is to be able to compare the new drug to a standard device existing on the market. The main thing is to be able to determine its effectiveness. Phase 3 requires several thousand patients to guarantee the expected result. It should be noted that the sponsor will have the right to apply for a marketing authorization if the results are favorable. The possibility of marketing the drug depends on the outcome of the application. Thereafter, a phase 4 is mandatory to conduct trials for long-term follow-up. This is an opportunity to identify the presence of side effects following the administration of the drug. At the same time, the drug will be evaluated to approve different conditions of administration.
EVERYTHING YOU NEED TO KNOW ABOUT CLINICAL TRIALS OF DRUGS
A clinical trial is highly regarded in order to ensure the development of a new drug. Each trial can show changes and improvements to the drug. The pharmacological activity of a drug requires numerous analyses and tests that can last for years to ensure efficiency. Phase 1 evaluates the effectiveness of the selected dose. Phase 2 is designed to confirm the previously administered dose. Phase 3 plays a comparative role to evaluate the magnitude of the results. Finally, phase 4 involves testing to identify side effects.