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Location： Home Service Items Non-GLP Safety Assessment
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Non-GLP Safety Assessment
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Non-GLP Safety Assessment

Non-GLP toxicology studies are typically applied in the early stages of drug discovery and preliminary toxicological assessments. Their primary purpose is to explore the toxicological characteristics of new compounds in order to guide subsequent study design and project decisions. Zvast Bio has established an AAALAC internationally accredited SPF-level animal facility, equipped with comprehensive clinical testing equipment as well as instruments for histopathology and physiological assessments. The company can provide non-GLP early toxicity evaluation services for drugs, offering sufficient safety data for druggability assessments.

The research scope of non-GLP toxicology is toxicology-related research carried out without following Good Laboratory Practices (GLP), and the core focuses on rapid screening, preliminary exploration, mechanism research, and non-regulatory submission-oriented toxicology-related work, which complements GLP toxicology (standardized toxicological tests specially carried out for regulatory declarations of drugs, medical devices, chemicals, etc.), covering multiple types of toxicology-related scenarios from early research and development to basic research.


The research scope can be divided into the following core categories according to the research purpose, test type, and application scenario, and all types of research do not have the strict process, record, and quality system requirements of GLP, and the trial design is more flexible, the cycle is shorter, and the cost is lower:


1. Toxicological rapid screening and initial screening in the early research and development stage

  • Providing preliminary data for subsequent GLP toxicology tests or R&D decisions to avoid wasting R&D resources is the core scope of non-GLP toxicology research.


  • Initial screening of toxicity in vitro: such as cell survival/toxicity test (MTT, CCK-8), in vitro hemolytic test, in vitro screening for skin/mucosal irritation, preliminary detection of apoptosis/necrosis, etc.


  • Simplified in vivo pre-test: small sample size of animal acute toxicity pre-test (e.g., exploring the approximate range of LD50), general toxicity observation for short-term administration (non-standardized weight, diet, and visual signs monitoring);


  • Preliminary toxicity evaluation of compounds/raw materials: Preliminary toxicity grades of new drug candidates, cosmetic raw materials, food additives, and industrial chemicals, and low-toxicity/non-toxic candidates are screened out.


2. Study of Toxicological Mechanisms


  • Focusing on the fundamental scientific exploration of 'how toxicity occurs' rather than obtaining regulatory data on 'what the toxic dose is' is the core content of academic research and in-depth R&D optimization.


  • Molecular-level mechanisms: Such as the effects of toxic substances on cell signaling pathways, gene expression (PCR/sequencing), protein levels (WB/immunohistochemistry), and studies on toxic pathways like oxidative stress, inflammatory responses, and mitochondrial damage;


  • Cellular/tissue-level mechanisms: Such as the cellular mechanisms of target organ injury (e.g., hepatocyte lipid metabolism disorders in liver injury, apoptosis of renal tubular epithelial cells in kidney injury), and the cellular uptake/metabolic pathways of toxic substances;


  • Whole-animal mechanism validation: Using small sample studies to investigate the distribution of toxic substances in target organs, the toxicity of metabolic products, and the mechanisms of action of antagonistic/detoxifying substances.


Service Items


» Single-dose toxicity in small and large animals

» Repeated-dose toxicity in small and large animals

» Hemolysis / skin irritation

» Active / passive allergy

» Abnormal toxicity

» Histopathology testing

» Histopathology


Platform Capabilities

● Zvast Biotech's Early Toxicology Service Platform provides early toxicology studies with stable data and reliable quality. Flexible experimental design and scheduling, along with close communication with the histopathology department, can significantly shorten the project cycle of early toxicology trials, providing clients with timely and reliable toxicology evaluation data to accelerate drug development.


● The project implementation team of Zvast Biotech's Early Toxicology Service Platform is highly experienced in various administration and sample collection techniques, minimizing adverse effects on animals during experiments and enabling accurate evaluation of the test drug's toxic effects.

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