Non-clinical safety evaluation refers to the comprehensive evaluation of the safety of drug candidates through a series of in vitro and in vivo studies. It is a necessary and important step for IND applications for clinical trials or NDA/BLA submissions. InnoStar provides a complete set of strategies ranging from QSAR and in vitro toxicity screening, to preliminary in vivo toxicity studies to help our clients identify the toxic effects of potenital compounds at the early stage of drug discovery.
InnoStar provides comprehensive, highly standardized and high-quality services for non-clinical safety evaluation.
Successfully passing GLP inspections from the NMPA, OECD and FDA, InnoStar complies with international GLP standards and is capable of providing international services. InnoStar provides top solutions for non-clinical evaluation in emerging R&D fields including targets for tumor immunotherapy, new molecular development and delivery technologies, novel antibodies (bispecific and multispecific antibodies, ADCs, nanoantibodies, etc.), peptides and fusion proteins, nucleic acids and cell and gene therapy products (immune cell therapy products, stem cell therapy products, oncolytic viruses, AAV vector-based gene therapy products, etc.). InnoStar has extensive technical experience in the fields such as biomarkers for assessment of major target organ toxicity, genotoxicity assessment, dependence assessment, ophthalmology assessment and in vitro cardiotoxicity assessment. The company boasts a group of technicians with rich first-hand project experience to carry out high-quality non-clinical safety evaluation studies.
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