We offer a range of studies and tests to demonstrate the bioavailability, safety and efficacy of cannabis formulations, delivery systems and related technologies from medical to recreational, from human to pets.
Deciding whether a drug is ready for clinical trials involves extensive preclinical studies that yield preliminary efficacy, toxicity, pharmacokinetic and safety information. Wide doses of the drug are tested using in vitro (test tube or cell culture) and in vivo (in animals).
Phase I Clinical Trials
Studies assess the safety of a drug or device. This initial phase of testing can take several months to complete and is usually carried out on a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II Clinical Trials
Studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug.
Studies to investigate botanical agents, dietary ingredients and finished dietary supplements in terms of safety and efficacy, through the use of cell culture experiments, animal studies and human clinical trials.
In pharmacology, bioavailability is the degree and rate at which an administered formulation is absorbed by the body's circulatory system”. It is used to determine the correct dosage of any medication administered non-intravenously (not directly into the bloodstream), through pills, patches, suppositories, inhalable products and also edibles.