The Preclinical Research Process

The preclinical research process extends from early assessments of feasibility of pharmaceutical development to providing regulatory authorities and clinical trial units with information necessary for administering the product to human subjects. Chief concerns include safety, which is evaluated in well-defined preclinical toxicology programs, and efficacy, which must be defined in appropriate in vitro systems and animal models prior to entering the clinic. Pharmacological characterization in animal models defines activity and identifies site(s) and mechanism of action, effective dose range, optimal treatment regimens (route and frequency of administration), and quantifiable endpoints for monitoring the pharmacodynamic behavior of the drug in vivo. Results from these studies permit the toxicological studies to focus on relevant animal models and target tissues. They can also reveal new or modified activities for further safety assessment and examination in clinical trials. New experimental models and analytical methodologies often have to be developed and validated for the specific product under evaluation.