The activities involved in bringing a new drug to market after a lead compound has been identified are referred to as the drug development process. Once a single compound has been chosen, preclinical studies are conducted to determine whether it is safe and effective in treating the condition for which it was developed, as well as the proper dosage and administration route.
Prior to human clinical trials, both in vitro and in vivo models are commonly used to assess drug candidate safety and efficacy, providing crucial information on a compound's biological effects at this early stage in drug development. Drug effects can be visualized and evaluated at the cellular level or in the context of an animal model, and this information can be useful in determining efficacy, bio distribution, toxicity, and safety.