Safety Pharmacology Evaluation
Preclinical evaluation for innovative drugs plays an essential role in predicting potential drug toxicity before they are first applied to humans. Our company provides leading-edge safety pharmacology evaluation services and essential platforms to help you get ahead of the curve in the therapeutics development for autoimmune diseases & inflammation.
Overview of Safety Pharmacology
Safety pharmacology is one of the important elements of non-clinical safety evaluation of new drugs. Safety pharmacology studies the potential adverse effects of drugs on physiological functions within the therapeutic dose range, mainly observing the effects of drugs on the central nervous system, cardiovascular system and respiratory system. The objectives of safety pharmacology testing include the following:
- To elucidate unintended pharmacodynamic properties of a subject that may be relevant to human safety.
- To evaluate adverse pharmacodynamic and/or pathophysiologic effects of a subject observed in toxicology and/or clinical trials.
- To investigate the mechanisms of observed and suspected adverse pharmacodynamic effects.
Fig.1 Potential cross-talk between RTKs and TRPM7 and the potential involvement in RTKs inhibition-related cardiovascular toxicity (Liu Q., et al., 2023)
General Principles of Safety Pharmacology Evaluation
As pharmacologic effects vary according to the characteristics of each subject, the design of safety pharmacology tests should be based on the characteristics of the subject.
- To Study of potentially undesired adverse effects on physiological function when the drug is administered at doses within or above the therapeutic range, including the observation of the effects of the drug on the central nervous system, the cardiovascular system and the respiratory system.
- Based on the pharmacological action and chemical structure of the drug, if adverse reactions affecting safety are anticipated, follow-up safety pharmacology studies should be performed, with in-depth studies of the central nervous system, cardiovascular system and respiratory system.
- When there is a possibility of adverse effects on other target organs, supplemental safety pharmacology studies should also be performed to evaluate the drug's effects on the urinary system, autonomic nervous system, gastrointestinal system, and other organ tissues.
Our Services
With the development of molecular biology technology and its wide application in the medical field, it provides more and more choices and possibilities for the development of novel therapies for autoimmune diseases. Our company provides drug safety evaluation services with the support from multidisciplinary experts and utilization of various technological platforms.
Safety Pharmacology Core Combination Test
The purpose of the safety pharmacology core combination test is to study the effects of the subject material on vital functions of the human body, including vital organ systems such as the central nervous system, cardiovascular system, and respiratory system.
For Central Nervous System
- Coordinated Balance Motor Test
- Mouse Sleep Synergy Test
- Autonomous Activity Test
- Functional Observation Combination Test
For Cardiovascular System
- In Vivo Electrocardiogram Test
- hERG Channel Assay
For Respiratory Systems
- Respiratory Function Indicator Test
- Airway Resistance Test
- Pulmonary Artery Pressure Test
Our Advantages
Extensive Experience
We have extensive experience in drug safety evaluation.
Advanced Technology
We have advanced laboratory facilities and technology platforms.
Customizable Solution
We can provide customized solutions based on specific project objectives.
Competitive Price
Our prices for quality services are highly competitive.
Staffed by experts in novel drug discovery and researchers engaged in pharmacology and toxicology with a solid foundation in preclinical safety evaluation of therapeutic drugs, our company is committed to providing you with professional services in the development of therapeutic drugs for Autoimmune Diseases & Inflammation. If you are interested in our services, please don't hesitate to contact us.
Reference
- Liu, Qing et al. "Cardiovascular toxicity of tyrosine kinase inhibitors during cancer treatment: Potential involvement of TRPM7." Frontiers in cardiovascular medicine 10 (2023) 1002438.