The purpose of safety pharmacology evaluation is to predict and prevent unsafe factors during the use of a drug in human (or animal) populations. Our company has extensive expertise in drug safety evaluation, particularly in safety pharmacology evaluation, our professional scientists and advanced platforms provide efficient methods to accelerate rare disease therapy research and development.

Overview of Safety Pharmacology Evaluation

Safety pharmacology evaluation is an important part of the preclinical safety evaluation of new drugs, which evaluates and predicts the possible adverse reactions of new drugs in human clinical trials, including the central nervous system, cardiovascular system, respiratory system, gastrointestinal system, and renal system. In vitro, studies using molecular targets (enzymes, receptors, ion channels, etc.) suggest mechanisms by which a chemical may affect an organism, while in vivo evaluations are performed in intact and ideally unanesthetized animal models.

Fig.1 Safety Pharmacology evaluation of indole alkaloids. (Zhao, Yun-Li, et al., 2020)

When potential adverse reactions of a drug endanger human safety, additional and/or supplementary safety pharmacology studies should be conducted as necessary. The purpose of supplementary safety pharmacology studies is to evaluate the effects of test drugs on organ functions other than the central nervous system, cardiovascular system, and respiratory system, including studies on the urinary system, autonomic nervous system, gastrointestinal system, and other organ tissues.

Cardiovascular System Evaluation

With animal models such as canines, rats, mini-pigs, guinea pigs, non-human primates, the services provided include electrocardiograms (ECGs), heart rate, blood pressure, ventricular and pulmonary pressure, and echocardiography.