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

Inhalation Formulation Safety Assessment
Ophthalmology Safety Assessment

Clinicopathological Study

Medicilon's Clinicopathology Laboratory is a GLP-based medical laboratory affiliated to the Pathology Research Department. The laboratory is mainly responsible for animal biochemistry, hematology, coagulation, urine analysis, microscopic examination of urine sediment, lymphocyte typing, in vitro hemolysis, microscopic examination of marrow smear and animal physical examination, aiming to provide an accurate basis for experiments. The laboratory has participated in the room quality assessment by Shanghai Center for Clinical Laboratory and has been awarded certificates for three consecutive years with every item qualified. Our Clinicopathology Laboratory is equipped with advanced detection instruments for various tests involving blood and body fluids of various animal species, thus providing clients with comprehensive safety evaluation data support.

Learn more

Drug Safety Evaluation Basic Information

Medicilon has experienced teams who are experts in drug safety evaluation and can promise high-quality data and fast turnaround times to support various drug safety evaluation. Our toxicology research is carried out using different animals, from dose design, experimental research to histological and pathological research (including clinical detection). The research can be carried out according to non-GLP or GLP standards. Our research platform has been rated as Shanghai R&D Public Service Platform.

Learn more

Toxicokinetics

Medicilon has complete pharmacokinetic, toxicokinetic and analytical research facilities and instruments. Our Toxicology Research Department has been granted AAALAC Accreditation and GLP certificate from the NMPA and passed the on-site evaluation, with capabilities to support filing programs for multiple countries.

Learn more