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Drug Safety Evaluation

Drug Safety Evaluation

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.

Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

Toxicology Services:
  • GLP & Non-GLP
    Single/multiple dose toxicity studiesSafety Pharmacology Research Reproductive toxicity studiesImmunogenicity studies Genotoxicity studies Local toxicity studies Toxicokinetic studies Carcinogenicity studies
    Internationally recognized pathology support

    Histopathology Studies

    HE staining Special stainingImmunohistochemistry (IHC) Tissue Cross-Reaction Test (TCR)

    Clinical Pathology Studies

    Hematology Analysis UrinalysisClinical Biochemistry Analysis Hemocoagulation Analysis Lymphocyte typing
New Drug Delivery Technology
Pharmacology & Toxicology Study

We use professional teams with significant practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research can be carried out according to non-GLP or GLP standards. Our research platform has been selected as a Shanghai R&D Public Service Platform. 

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Reproductive Toxicity

The study of reproductive toxicity is an important step in the clinical research and marketing authorization of pharmaceuticals. Aimed at revealing the impact of drugs on mammalian reproductive functions, and embryonic and fetal development, these studies constitute a vital aspect of non-clinical safety assessment of drugs. The main purpose is to reflect the impact of the test substance on the reproductive function and development process of mammals through animal testing, and to predict its possible adverse effects on reproductive cells, fertility, pregnancy, delivery, lactation and other parental reproductive functions, as well as the adverse effects on the embryo-fetal development of the offspring and post-natal development.

Based on the research and development strategy and timeline, combined with the structural characteristics, physical and chemical properties, pharmacological and toxicological information, indications, applicable populations, clinical medication plans, etc., Medicilon will provide clients with flexible solutions design and execution for stage I, II and III reproductive studies to help to conduct the clinical studies smoothly.

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Genotoxicity Study
Genotoxicity study is an important part of non-clinical safety evaluation of drugs, which is closely correlated to other studies, especially carcinogenicity and reproductive toxicity studies, and it represent a crucial phase for clinical trials and the marketing authorization of drugs. For drugs intended to be used in humans, genotoxicity tests should be conducted based on factors such as the intended indications and mechanism of action of the test substance. Our genotoxicity test services include Ames test, Mini-Ames test, chromosomal aberration test and micronucleus test, etc.
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General Toxicology
General toxicology covers single and repeated dose studies of various durations (from acute toxicity to chronic toxicity) up to 2-year carcinogenicity studies. According to clients and regulatory requirements, we can conduct GLP and non-GLP studies of different species, scale, duration, complexity and compliance. The company's R&D platform was rated as the Shanghai R&D Public Service Platform. Medicilon is one of the earliest CRO companies in China that builds preclinical animal experimental facilities based on advanced experience in the United States. The company has GLP qualifications for both China and the United States, and has passed AAALAC certification. The GLP laboratory area reaches 29,000 square meters.
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Safety Pharmacology
We can provide safe pharmacological experiment services using large and small animals species to explore the effects of drugs on central nervous system, respiratory system and cardiovascular system, and to support drug R&D.
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Histopathological Study

In diagnosis, histopathological diagnosis is considered as the gold standard to determine diseases and their status. Before the body shows obvious clinical symptoms, the influence of drugs on the body tissues and organs can be found through histopathological examination, so providing a reference for the prevention and treatment of diseases. In drug filing, relevant institutions pay great attention to the results of histopathological diagnosis because such results can provide an important basis for judging the potential harm degree of the drugs to be filed. The guidelines issued by various regulatory agencies also require histopathological diagnosis results of short-term toxicity, sub chronic toxicity, chronic toxicity and carcinogenicity tests. As a comprehensive CRO, Medicilon provides extensive, high quality services in histopathology.

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