Safety Pharmacology

Introduction

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.

Why conduct safety pharmacology studies?

• To determine the undesired pharmacological effects of a drug that may be relevant to human safety.
• To evaluate the adverse drug reactions observed in the toxicology of the drug.
• To study the observed and presumed mechanisms of adverse drug reactions.

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.

Safety Pharmacology Studies

• Safety Pharmacology Core Battery Studies

• Follow-up Safety Pharmacology Studies

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.

• Supplemental Safety Pharmacology Studies

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.

Our Safety Pharmacology Services

• Dose-response relationships for the observed adverse reactions in the subject animals.
• In vitro studies to determine the concentration-effect relationship of the drugs.
• Design of single or repeated doses.
• Select the time point and duration of observation, taking into account the PD/PK properties of the drugs, and the subject animal.

Why Choose BOC Sciences?

• Well-established preclinical assays for the propensity for adverse reactions to new chemical entities (NCE)
• Organize method implementation strategies according to regulatory guidance documents
• Guidance for safety evaluation of additional physiological systems
• Development of translatable non-clinical safety pharmacology methods
• Pursuit of low cost and high success rates in drug development
• Advanced safety pharmacology data collection and analysis techniques
• High detection sensitivity and high predictability of adverse event development
• Extensive safety pharmacology expertise and a team of experienced experts
• Compliance with good laboratory practices (GLP)

What Can We Do?

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.