Exploring the Role of Preclinical Toxicology Tests in Vaccine Development
The vaccine is a generic term for various biological products containing antigenic substances that induce specific active immunity in humans. In preclinical studies of vaccine, it is crucial to examine the safety of vaccines by performing preclinical safety evaluations with relevant animals. Drug safety evaluation in preclinical studies of new medicines refers to the use of greater than clinical doses or more prolonged than clinical dosing times to administer drugs to animals to discover and evaluate the potential toxic effects on the animal organism, the manifestations of toxicity, and the reversibility of target organ damage. This study helps to find toxic doses, detect harmful effects, determine safe dose ranges, search for unhealthy target organs, and assess the reversibility of toxicity. The difficulty of drug safety evaluation in vaccines is that the vaccine does not directly exert preventive or therapeutic effects but acts by inducing the immune system to produce antibo...