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.

Image removed.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.

Applications of Safety Pharmacology Evaluation

  • Assisting in the selection of candidate compounds in early drug discovery.
  • Evaluate potential risks and adverse effects of drugs in preclinical studies.
  • Signals identified in preclinical studies can serve as biomarker candidates.
  • During clinical development, explain predicted and unpredicted side effect