Drug Toxicology and safety Evaluation

The drug toxicity research and safety evaluation center is composed of a group of experienced professional scientific research teams. It has established a safety evaluation system in line with international standards. The experimental research follows the guidance and responsibilities of nmpa, ICH and FDA, and provides high-quality and efficient drug non clinical safety evaluation services.

Pharmacokinetics

The non clinical pharmacokinetic service department has a group of experienced senior professionals who are in charge of experimental design, experimental implementation, biological analysis and data analysis. The experiment follows the guiding principles of NMPA, and can design and carry out in vivo and in vitro pharmacokinetic experiments as required by customers so as to provide customers with a complete set of pharmacokinetic evaluation and optimization services. High quality data and high efficiency test cycle meet the demands of customers from early drug discovery to new drug application.

Pharmacological Efficacy

The non-clinical pharmacology and pharmacodynamics service department has a professional team with professional backgrounds covering pharmacology, molecular pharmacology, neuropharmacology, cell biology, molecular biology, immunology and veterinary science. The business areas include large scale in vivo and in vitro screening of gene therapy drugs, antibody drugs, cytokines, protein drugs and chemical drugs, and preclinical effectiveness evaluation research applicable to domestic and foreign applications.Extensive experience in drug screening and a complete set of advanced screening technology support the drug development projects of the entrusting party. It improves the success rate of new drug research and development, reduce research and development expenses and shorten the time for research and development of new drugs.

Molecular Imaging Center

Topgene Biotechnology’s Molecular Imaging Center is dedicated to non-human primate molecular imaging, drug screening and preclinical evaluation, and CRO services. The molecular imaging center provides molecular imaging drug research and development outsourcing, drug radiolabeling synthesis, new PET imaging agent research, tumor therapy and targeted therapy technology services. It is committed to PET molecular imaging, which combines the molecular imaging technology of functional and structural imaging. It applies imaging means to display specific molecules at the tissue level, cell and subcellular level to reflect the changes at the molecular level in the living state, and conduct qualitative and quantitative drug research of the imaging of its biological behavior.

Biological Analysis

The analysis department boasts a professional scientific research team, and is provided with advanced instruments and equipment, carries out integrated information management, and experimental research following the GLP/GCLP standardized management. The service content involves pharmacokinetics, pharmacodynamics, immunogenicity, bioequivalence, etc. It can carry out the screening and development of macromolecular drugs, small molecule drugs, macromolecular drugs and biomarkers, non clinical research, provide the writing, analysis, summary and statistical analysis of biological sample analysis schemes that meet the application requirements, and submit analysis reports.

Biological Statistics

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