Overview of Drug Safety Evaluation

New types of drugs and new preparations are constantly emerging, and various safety issues are also arising. The purpose of drug safety evaluation is to determine the safe amounts and timing of drugs to avoid the occurrence of adverse events. Drug safety evaluation is a necessary procedure and an important step before new drugs enter final clinical trials and final approval. Traditional drug safety evaluation technologies and methods can no longer meet the growing needs. Research focuses on finding and establishing fast and accurate drug safety evaluation technologies and methods.

Applications of Drug Safety Evaluation

Discovery of the toxic dose

Understand the toxic dose after a single administration, and initially understand the dose range that will produce toxic reactions when administered multiple times, which provides a basis for further toxicity studies and/or clinical study design.

Determination of safe dosage range

Understand the dosage range within which the drug is effective without causing toxic side effects when administered single or repeatedly, providing information for clinical drug safety and observation of toxic and side effects.

Discovery of toxic target organs

When toxic effects occur in animals, the organs or tissues involved in the toxicological effects of the drug are discovered, which provides a basis for monitoring the toxic and side effects of clinical drugs and modifying the structure of new drugs.

Determination of toxicity reversibility

Understand whether the toxic effects of drugs on the body can be recovered, as well as the extent and time required for recovery, which provides a basis for further research on new drugs.