Toxicology Studies
InquiryOverview of Toxicology Studies
Protheragen is committed to providing comprehensive and in-depth toxicology services, aiming to safely evaluate anti-obesity therapeutics through scientific means. Our services not only cover the classical toxicological assessment of acute toxicity, sub-chronic toxicity, chronic toxicity, and genotoxicity, but also incorporate the cutting-edge methods of modern biotechnology, such as genomics, proteomics, and metabolomics, to more accurately reveal the mechanism of action and toxicity effects of anti-obesity therapeutics.
Analyze Precisely and Stay Away from Risk
Toxic effect is the main factor of R&D failure in preclinical and clinical stages. Our company has experts and experimental technicians with rich experience in toxicology to provide standard and scientific test design, professional data collection, analysis, and evaluation services.
Early In Vitro Toxicity Testing
Our company has crafted a one-stop in vitro early toxicity testing solution designed to accurately capture and reveal potential toxicity at the nascent stage of anti-obesity therapeutics development. Relying on advanced high-throughput screening and electrophysiological evaluation, we have built an efficient and cost-optimized early toxicology service system. This system not only provides rapid and comprehensive characterization of the toxicity but also provides in-depth insight into their toxicological mechanisms, presenting clients with a clear and comprehensive picture of potential toxicological risks.
Key Toxicology Testing
Toxicology studies at the preclinical stage are a mandatory step in the development of anti-obesity therapeutics. Our toxicologists provide reliable toxicology study services to clients including but not limited to general toxicology tests, developmental and reproductive toxicology, genetic toxicology studies, and immunotoxicology studies.
- Single dose toxicity test (rodent and non-rodent)
- Repeated administration toxicity test (rodents and non-rodents)
- Local toxicity tests (hemolysis, allergy, irritation tests)
- Maximum tolerance test
- Hematological and biochemistry analysis: Hematology; Serum biochemistry
- Reproductive toxicity tests: Fertility and early embryonic development toxicity test; Embryo-fetal development toxicity test; Perinatal toxicity test
- Immunogenicity test
- Toxicokinetics
- Carcinogenicity studies
- Dose exploration tests
- Neurotoxicity assessment: Functional observation battery (FOB); Motor function assessment (MA)
- Genotoxicity testing: Genetic mutation studies: Bacterial mutation test; Mammalian mutation test
Workflow
The service process of toxicology studies usually involves a series of rigorous and systematic steps, and we provide personalized toxicology studies to ensure the scientific accuracy of our services. Our researchers provide professional experimental design and protocol development services including animal model selection, cell model selection, and experimental protocol planning (grouping, routes of administration and dosage, and observation indicators). Our staff records the behavior of animals, physiological indicators, tissue samples, and other data during the experiment for subsequent analysis. Finally, we apply statistical methods to process and analyze the experimental data to compare the differences between the experimental and control groups.
Applications
- Toxicology studies can be used to identify safe dose ranges and toxicity profiles of different types of anti-obesity drugs and to predict possible clinical dosing risks.
- Toxicology studies allow systematic assessment of the potential toxicity of anti-obesity therapeutics in animal models, including acute toxicity, chronic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity.
- Toxicology studies can be used to predict the metabolic process, mechanism of action, and possible side effects of anti-obesity therapeutics in the body.
Advantages of Us
- Our researchers have extensive experience in many toxicological studies, including acute toxicity tests, long-term toxicity tests, and genotoxicity tests.
- Our company offers organ- and system-specific toxicology analysis services to meet our clients' research needs.
- Our company focuses on the authenticity and reliability of the experimental data and ensures the accuracy and reproducibility of the data through strict experimental design and operation specifications.
One-Stop Obesity Solution
In anti-obesity research, our researchers use advanced tools to pinpoint key targets in obesity pathology. We validate the potential efficacy of anti-obesity therapies in rigorous in vitro experiments and animal models. We minimize translational risk through robust preclinical studies that comprehensively assess the safety and efficacy of therapies.
Combining biology, statistics, and informatics, our company aims to delve into the pathogenesis of obesity, evaluate the effectiveness of interventions, and predict the risk of obesity-related diseases. Our researchers comprehensively analyze the mechanisms of obesity-related factors, the causes of energy metabolism imbalance, and the relationship between obesity and other diseases.
Publication Data
Technology: Acute oral toxicity study, Sub-acute oral toxicity study, Hematological and biochemistry analysis, Urine analysis
Journal: Brazilian Journal of Biology
Published: 2022
Results: In this study, researchers conducted a series of experiments to evaluate the acute and subacute toxicity of anti-obesity polyherbal granules (PHG) in Sprague Dawley rats. After a single administration, no significant behavioral abnormalities, weight loss, or death were observed in any of the dose groups. After continuous administration, rats in all groups showed normal body weight gain and no significant abnormalities in hematology and blood biochemistry tests. The weights of major organs as well as pathological examinations showed no dose-related toxic effects. The results of this study provide preliminary safety data for the further development and clinical application of PHG.
Fig.1 Experimental flow chart for sub-acute oral toxicity study. (Patel, et al., 2022)
Frequently Asked Questions
What is detected in single and repeated dosing?
Single-dosing studies collect information on dose-response relationships that can be used to select doses for repeat-dosing toxicity studies. The route and regimen of administration for repeat dosing studies should reflect the clinically formulated use or use of the drug.
How do clients choose a high dose?
The pharmacodynamic study-pharmacokinetic study facilitates the selection of high doses. The maximum expected pharmacological dose of the preclinical test species and the dose that achieves approximately 10 times the maximum clinical exposure are identified in the preclinical toxicity study. The higher dose is selected as the dose for the preclinical toxicity test.
Protheragen has highly trained technicians and toxicologists to provide our clients with high-quality toxicology studies. Our goal is to provide clients with a one-stop solution from initial screening to in-depth mechanism study. Whatever your needs, please feel free to contact us for help!
Reference
- Patel, C.; et al. Acute and sub-acute toxicity study of anti-obesity herbal granules in Sprague Dawley rats. Brazilian Journal of Biology. 2022, 84: e264320.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.