Safety Pharmacology Evaluation
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.
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
Our Services
Safety pharmacology evaluation is an important step in assessing acute and potential risks of orphan drugs. Inefficient processes, inaccurate data, or unexpected challenges during preclinical development are causes of study delays. Our company has a professional team that can provide high-quality safety pharmacology evaluation services, helping you save a lot of time and money, and accurately evaluate the potential toxicity of rare disease drug candidates. Services we can provide include but are not limited to:
Central Nervous System Evaluation
With animal models such as mini pigs, dogs, rodents, and non-human primates, the services provided include functional observation battery (FOB) studies, modified Irwin screen, body temperature monitoring, and large animal neurological evaluations.
Our company provides plethysmography in rodent and large animals with CV telemetry to support respiratory system evaluation services, we can perform tests such as hemoglobin oxygen saturation, respiratory rate, tidal volume and minute volume.
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.
The hERG (human Ether-a-go-go related gene) test is used to gauge hERG channel protein activity. Our company provides automated patch-clamp, conventional patch-clamp and FluxORTM thallium assay to support hERG tests.
In addition to the above services, our company also provides supplemental safety pharmacology studies to further understand the mechanistic effects on life functions and evaluate potential adverse effects on other organ systems, including renal/urinary system study and gastrointestinal (GI) system study.
Why Choose Us?
- Economical pricing and fast turnaround time
- Professional technical support
- Customized services and products tailored to your research
- The rich experience accumulated in successful cases of new drug development
- Timely project reporting and after-sales service
Project Workflow
With a research team with extensive expertise in drug safety evaluation, our company is confident to provide clients with safety pharmacology evaluation services for rare diseases. We have the capabilities and resources to provide professional communication and problem-solving support to ensure that we can quickly respond to the changing needs of your rare disease therapy research projects. If you are interested in our services, please feel free to contact us for more information.
Reference
- Zhao, Yun-Li, et al. "Genotoxicity and Safety Pharmacology Studies of Indole Alkaloids Extract from Leaves of Alstonia scholaris (L.) R. Br." Natural Products and Bioprospecting 10 (2020): 119-129.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.