Toxicology and pharmacokinetics
Toxicology determines the extent of any side effects seen in the body. The studies aim to evaluate the extent to which the drug substance in the drug candidate LIB-01 is toxic to the user. As all chemicals are considered to have some toxic effect if the dose is large enough, the study will also conclude what the maximum dose can be in future trials.
Dicot's toxicological program consists of studies on rodents and non-rodents, which is a requirement from the pharmaceutical authorities. Rats and dogs are the most common laboratory animals used in this type of study.
Studies of a drug candidate's toxicity constitute a necessary and important part of the authorities' assessment prior to clinical trials and will form the basis for Dicot's application for clinical trials in healthy human subjects.