General Toxicity 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 general toxicity evaluation services and essential platforms to help you get ahead of the curve in the therapeutics development for autoimmune diseases & inflammation.
Overview of Non-clinical Safety Evaluation
Drug development is a step-by-step process involving the evaluation of efficacy and safety information in animals and humans. Non-clinical safety evaluations generally include the relationship of the toxic response to the target organ, dose dependence, exposure relationship, and potential reversibility. These drug toxicity data can be used to estimate safe starting doses and dose ranges for human clinical trials and to identify potential indicators of adverse effects in clinical monitoring. At the start of clinical development, although information from non-clinical safety studies is usually limited, it should be possible to adequately elucidate the potential adverse reactions that may occur in the clinical trials supported by the drug.
Fig.1 A schematic diagram illustrating potential cellular mechanisms of microplastics/nanoplastics toxicity. (Yong C.Q.Y., et al., 2020)
General Toxicity Evaluation
General toxicity evaluation refers to the toxic reactions of various tissues and organs of the whole body caused by the absorption of drugs into the bloodstream through different routes of administration. General toxicity study is the most basic content of non-clinical safety evaluation of drugs, mainly including acute toxicity study and long-term toxicity study.
Acute Toxicity Study
Acute toxicity studies refer to the study of toxic reactions in experimental animals within a certain period of time after repeated doses of a drug for 1 time or 24 hours. Acute toxicity study is generally carried out in the early stage of drug toxicology research, which is the first step in the evaluation and study of the toxic effects of drugs on the organism, and can initially elucidate the nature of the toxic effects of the drug and dosage, determine the toxicity of the target organ, and provide reference information for the dosage design of the repeated-dose toxicity study.
Chronic Toxicity Study
Chronic toxicity studies, also known as repeated dose toxicity studies, are studies that characterize the toxic response of experimental animals after repeated doses of drugs. The chronic toxicity study is one of the toxicological studies that obtains the most information and has the greatest significance for clinical guidance in the non-clinical toxicological study of drugs, which allows for the determination of the nature and extent of adverse reactions triggered by long-term administration of a drug, dose-response relationships, time-response relationships, reversibility and other toxicological characteristics.
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, including but not limited as:
Acute toxicity Study
Acute toxicity is usually observed in terms of death or obvious toxic reactions in experimental animals, and we can evaluate the following parameters according to the specific experimental design:
- Maximal Feasible Dose (MFD)
- Maximal Tolerance Dose (MTD)
- Median Lethal Dose (LD50)
- No Observed Adverse Effect Level (NOAEL)
- Minimal Lethal Dose (MLD)
- Approximate Lethal Dose (ALD)
Chronic Toxicity Study
Chronic toxicity studies focus on the toxic effects, target organs and reversibility of toxicity in experimental animals after repeated administration, and we provide the following tests and evaluations:
- Clinical Observation
- Hematology
- Blood Biochemical Tests
- Urine Analysis and Observation
- Histopathologic Examination
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
- Yong, Cheryl Qian Ying et al. "Toxicity of Microplastics and Nanoplastics in Mammalian Systems." International journal of environmental research and public health 17,5 (2020): 1509.