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.

The significance of general toxicology includes:

Understanding the acute toxicity and tolerated dose of drugs on the body, which is the most fundamental work in toxicology research;Observing the spectrum of toxic effects, characteristics of toxicity, and target organs affected by drugs to understand their toxic mechanisms;Confirming whether the damage caused by drug toxicity is reversible;Studying the dose-response relationship of repeated exposure to test substances, from preliminary understanding to determination of the No-Observed-Adverse-Effect Level (NOAEL) and the Lowest-Observed-Adverse-Effect Level (LOAEL) for establishing reference values for the safe limits in clinical trials;Determine the differences in the toxic effects of different animal species on the test substance to provide a basis for extrapolating the research results to humans.

Services (GLP or non-GLP)

Acute Toxicity Test (MTD)Toxicokinetic testRepeated dose toxicity test (dose range finding studies, subchronic and chronic toxicity testing)Carcinogenicity test

Animal species

Rodents (rats, mice, guinea pigs, etc.)Non-rodents (rabbits, dogs, monkeys, mini pigs, etc.)

Route of administration

OralTransdermalIntravenousInhalationalOphthalmicSublingualIntraperitonealIntrathecal Others (such as rectum, etc.)

Advantages

Medicilon has an experienced team of study directors and pathologists, many of whom are certified toxicologists and pathologists in China and the United States.The Provantis GLP Tox Data Collection System has been established in accordance with international standards for toxicology data management.Data is processed in the SEND format to ensure that clinical research submissions meet FDA requirements.Medicilon has rat, dog, and monkey rooms that meet GLP standards and can undertake non-clinical general toxicity tests on various rodents and non-rodent animals. The company has advanced analytical instruments that can meet the biological analysis of small molecules and biomolecules.Medicilon has cooperated with MPI in the United States and inherited [MPI’s Quality Management System/SOP]Comprehensive quality control measures [Three-level QC management method]As of December 15^th, 2023, Medicilon has completed 24 complete IND projects (including APIs, preparations, PD, PK, and safety evaluation).

Relevant articles

Reproductive Toxicity Genotoxicity Study General Toxicology