All therapeutic compounds must undergo a series of tightly regulated steps before the Food and Drug Administration (FDA) will approve the drug for prescription use in humans. The first step is in vitro (outside the body) tests to determine the viability of a compound. Next the compound is tested in animals beginning with mice and usually ending with primates. The third step is testing of the drug in clinical trials in human volunteers. There are three phases of clinical trials that must be performed in order for the drug to be approved by the Food and Drug Administration to treat a disease or condition.
Phase I clinical trials are performed with a small number of individuals, usually healthy participants. The goal of these studies is to measure the safety of the drug including its toxicity and adverse effects. Phase I trials also often measure how the drug is metabolized and excreted.
Phase II clinical trials continue to measure the safety of a drug but are conducted with a larger number of people, usually suffering from a specific disease that the drug is being tested to treat. These trials also begin to assess the efficacy of a drug to determine what effect it has on the indicated disease/condition. This is done by comparing the drug to an already available drug or a placebo.
Phase III clinical trials continue to measure the effectiveness and safety of a drug by evaluating its effects on a larger and more diverse group of people suffering from the intended disease/condition. Various doses of the drug may be studied as well its use in combination with other drugs.
Upon successful completion of Phase III clinical trials, FDA approval is granted for use in people with the condition/disease that the drug was intended to treat.
There is much to be understood about cannabinoids as medicine, and science has only recently begun to solve some of the mysteries. Clinical trials are necessary in order to create new uniform medications with cannabinoids. Cannabis Science is entering the FDA by applying for an Investigational New Drug, and clinical trials are an integral part of this process. Depending on which product is being tested and the stage of its development, we will enroll patients in pilot studies, then increase our focus on a larger scale. We will gather data diligently with each group, and compare our formulations to drugs which are currently available on the market for a myriad of diseases. Cannabis Science plans to first focus on cancer, then branch out into other illnesses.
If you are interested in taking part in a clinical trial, please contact us or fill out the form below.
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