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Overview of approaches and applications of deep learning in toxicologic pathology during nonclinical safety evaluation of drugs
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Di ZHANG1, Zhen-long YAN2, Yan-wei YANG1, Zhe QU1, Gui-tao HUO1, Shuang-xing LI1, Zhi LIN1, Jian-jun LÜ3
Chinese Journal of New Drugs | 2023, 32(21) : 2147 - 2154
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Chinese Journal of New Drugs | 2023, 32(21): 2147-2154
Overview of approaches and applications of deep learning in toxicologic pathology during nonclinical safety evaluation of drugs
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Di ZHANG1, Zhen-long YAN2, Yan-wei YANG1, Zhe QU1, Gui-tao HUO1, Shuang-xing LI1, Zhi LIN1, Jian-jun LÜ3
Affiliations
  • 1National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing Key Laboratory, Beijing 100176, China
  • 2Innostar Biotechnology Nantong Co., Ltd., Nantong 226133, China
  • 3Hubei Topgene Xinsheng Biotechnology Co., Ltd., Wuhan 430207, China
Published: 2023-11-15
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Histopathology data of toxicology studies during nonclinical safety evaluation of drugs are critical during the drug discovery and development process that is necessary for regulatory bodies to assess drug-related toxicity in laboratory animals and its impact on human safety in clinical trials. Artificial intelligence (AI) has been widely used in clinical medical practice with progress in the whole slide image (WSI), digital pathology and algorithms. However, the progress of machine learning (ML)-in particular, deep learning (DL)-has been rather slow in toxicologic pathology of nonclinical toxicology studies. This paper briefly reviews the role of toxicologic pathology in drug discovery and development, overview of AI and approaches of DL, applications of approaches of DL in toxicologic pathology, as well as the challenges in implementation of approaches of DL in toxicologic pathology, in order to provide reference for implementation of approaches of DL in toxicologic pathology for toxicology studies during nonclinical safety evaluation of drugs in China.

drug  /  nonclinical safety evaluation  /  toxicologic pathology  /  artificial intelligence  /  deep learning
Di ZHANG, Zhen-long YAN, Yan-wei YANG, Zhe QU, Gui-tao HUO, Shuang-xing LI, Zhi LIN, Jian-jun LÜ. Overview of approaches and applications of deep learning in toxicologic pathology during nonclinical safety evaluation of drugs[J]. Chinese Journal of New Drugs, 2023 , 32 (21) : 2147 -2154 .
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  • Online Date：2026-03-05
  • Published：2023-11-15
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  • Accepted：2023-06-28
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Affiliations
    1National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing Key Laboratory, Beijing 100176, China
    2Innostar Biotechnology Nantong Co., Ltd., Nantong 226133, China
    3Hubei Topgene Xinsheng Biotechnology Co., Ltd., Wuhan 430207, China
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多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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