Safety Assessment of Anti-Obesity Therapeutics
InquiryOverview of Safety Assessment
Obesity has evolved into a global problem. It is associated with a wide range of chronic diseases, such as osteoarthritis, sleep apnea, gallstones, fatty liver, hypertension, diabetes, and certain cancers. Although several therapies have been used to treat obesity, many of the approved and marketed anti-obesity drugs have been withdrawn due to serious side effects. Therefore, the necessary safety assessment is a critical step in Preclinical Studies of Anti-Obesity Therapeutics. Protheragen provides high-quality Obesity Models for Pharmacodynamic Study, Pharmacokinetic Study, Bioanalysis, and safety assessment.
Your Most Trusted Safety Assessment Partner
Protheragen provides two main types of security assessments including safety pharmacology studies and toxicology studies.
Safety Pharmacology Studies
Our company provides safety pharmacology experimental services in a wide range of animals to investigate the effects of anti-obesity therapeutics on the central nervous system, respiratory system cardiovascular system, etc., and to support the development of novel anti-obesity therapeutics.
Based on the constructed obesity model, our researchers provide testing services for the digestive system autonomic nervous system, urinary system, and other organ tissues. These testing services include a thorough evaluation of potential anti-obesity therapeutic drugs to ensure that they do not cause unwanted side effects in preclinical studies. Our research team uses advanced testing equipment and techniques to accurately analyze the dose-dependent response of a drug, providing reliable data for subsequent clinical trials.
Toxicology Studies
Our company provides a full range of toxicology services, with particular expertise in preclinical animal toxicology testing related to anti-obesity therapies, including rodent and non-rodent 14- or 28-day animal toxicology. By conducting comprehensive toxicology assessments, we aim to ensure the safety profile of anti-obesity medications, minimizing the risk of adverse reactions.
- General toxicology tests
Our company provides specialized general toxicity testing research services for anti-obesity therapeutics. Our professional researchers provide early toxicological evaluations such as tolerance, dose exploration, single administration, repeated administration, etc. - Developmental and reproductive toxicology
With state-of-the-art analytical equipment and skilled staff, we offer reliable reproductive toxicology studies such as maternal general toxicity and embryo-fetal developmental toxicity analyses. - Genetic toxicology studies
Based on high-level in vitro and in vivo tests, our company offers specialized services for the detection of gene mutations, chromosomal aberrations, and DNA damage. - Immunotoxicology studies
Our company conducts immunotoxicology studies to evaluate the potential effects of anti-therapeutics drugs on the immune system. Our immunotoxicology assessments include evaluating the impact of the drug on immune cell populations, cytokine production, and immune organ histopathology.
Workflow
Our expert safety evaluation team provides clients with personalized solutions to meet their needs in anti-obesity therapies. Our experienced researchers identify client's needs and provide protocol design services. We provide obesity model selection, personalized model development services, comprehensive safety assessments, and data validation.
Applications
- Safety assessment can be used to assess the safety and independence of a wide range of samples such as small molecules, biologics, natural products, and vaccines.
- Safety assessments can be used to identify potential problems in therapies and thus optimize therapy design to improve efficacy and reduce side effects.
- Safety assessments help to understand the long-term effects of the therapy, including effects on the cardiovascular system, metabolic system, and other body systems.
- Safety assessments can be used for potential risk assessment.
Advantages of Us
- Our experienced toxicology team provides clients with a comprehensive and reliable data package, from experimental design to study parameters.
- Our company has abundant animal resources and researchers with rich modeling experience, which greatly shortens the project period.
- Our company supports the customization of indicators and provides comprehensive testing and analysis services according to client's needs.
Delving into the Story of Obesity
Our company closely integrates biomedical and data analytics technologies to help deeply explore, understand, and address obesity. In our quest to explore efficient treatment options for obesity, we have delved into the multiple mechanisms of obesity.
Our research focuses on the following core areas: obesity causation, biomarker development, obesity prediction, microbiota regulation, and pathology. Our obesity research and diagnostic tests are designed to meet your diverse needs in the field of obesity research.
Publication Data
Technology: Next-generation sequencing, Biochemical parameter analysis
Journal: Nutrients
Published: 2020
IF: 5.9
Results: In this study, researchers evaluated the long-term oral safety of the Bacteroides uniformis CECT 7771 strain through a sub-chronic (90-day) oral toxicity. It has shown protective effects against metabolic disorders and obesity in preclinical trials. The researchers designed a repeated-dose oral toxicity assay in 9-week-old male and female rats to assess the chronic toxicity of B. uniformis CECT 7771 by blood biochemical parameters and histopathology. Animal model studies showed no significant adverse effects on growth, organ health, or biochemical markers after administration.
Fig.1 Plot of serum amylase activity measurement data. (Gómez del Pulgar, et al.,
2020)
Frequently Asked Questions
What are the main components of preclinical safety testing?
Preclinical safety testing includes general principles, bioactivity/pharmacodynamic studies, animal species/model selection, number of animals/sex, route of administration/dose selection, and immunogenicity.
Which animals are used in general toxicology studies?
Rodents (rats, mice, guinea pigs, etc.) and non-rodents (rabbits, dogs, monkeys, miniature pigs, etc.) are often used in general toxicology studies.
Protheragen provides safety assessment services including but not limited to safety pharmacology studies and toxicology studies to clients all over the world. We have received praise from our clients for our conscientious and responsible attitude. Please feel free to contact us.
Reference
- Gómez del Pulgar, E.M.; et al. Safety assessment of Bacteroides uniformis CECT 7771, a symbiont of the gut microbiota in infants. Nutrients. 2020, 12(2): 551.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.