Safety pharmacology is a component of the field of preclinical safety evaluation of new drugs, mainly applying in vivo and in vitro methods in experimental animals to evaluate and predict the possible adverse effects of new drugs in human clinical trials, and is of general interest to new drug researchers and developers because of its importance.
Safety pharmacology focuses on the study of potential undesired adverse effects on physiological functions of drugs at doses within or above the therapeutic range, mainly observing the effects of drugs on the central nervous system (CNS), cardiovascular system and respiratory system. Safety pharmacology requires consideration of the physicochemical and pharmacological properties of the compound, as well as the toxicology and associated pharmacokinetic (absorption, distribution, metabolism, and excretion, ADME) results. Follow-up and/or supplemental safety pharmacology studies are conducted as needed when potential adverse drug reactions lead to safety concerns in humans.
The purpose of safety pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PD/PK) relationship of adverse drug reactions using a variety of methods. Unlike toxicology, safety pharmacology involves the regulatory requirement to predict the risk of rare fatal events. The key issues in safety pharmacology are the detection of adverse reaction liability and the application of the data to the ultimate clinical safety monitoring.
|Central nervous system
In-depth studies of the CNS, cardiovascular system, and respiratory system, should be performed if doubts arise about the results of existing animal and/or clinical trials that may affect human safety.
Evaluate the effect of the tested drug on the function of organs other than the above three organs, including studies on the urinary system, renal system, gastrointestinal system, and other organ tissues.
BOC Sciences provides high-quality safety pharmacology services by designing tests rationally and selecting validated methods based on the characteristics of the drug and the purpose of clinical use. We make recommendations for clinical studies through detailed test records, which should be combined with a comprehensive evaluation of efficacy, toxicology, and PD/PK.