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Discussion of emergency management strategies of investigational new drugs in first-in-human clinical trial
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Ying-ying FANG, Xing-he WANG
Chinese Journal of New Drugs | 2023, 32(22) : 2306 - 2310
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Chinese Journal of New Drugs | 2023, 32(22): 2306-2310
Discussion of emergency management strategies of investigational new drugs in first-in-human clinical trial
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Ying-ying FANG, Xing-he WANG
Affiliations
  • Phase I Clinical Trial Center, Beijing Shijitan Hospital of Capital Medical University, Beijing 100038, China
Published: 2023-11-30
Outline
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With the rising of investigational new drugs in clinical trials, the risk of adverse events is increasing as many aspects of the innovation medicine need to be explored. The first-in-human clinical trial (FIH) was retrieved in PubMed from January 1, 2009 to October 31, 2022. The types of drugs and the proportion of adverse drug reactions (ADRs) were analyzed. The number of innovative drugs in FIH during 2021-2022 was 37.4% of the number during 2009-2020. In terms of large molecule drugs, the proportion of ADRs reported in the period 2021-2022 is higher than the proportion in 2009-2020 (15.63% vs 12.66%). Importantly, the proportion of monoclonal antibodies with ADRs in 2021-2022 was also higher than that in 2009-2020 (27.59% vs 11.32%). Strengthen risk awareness and the risk of acute insight play significant important role in early warning and prevention of adverse events in FIH. At the same time, the key elements of emergency management and principles of emergency treatment are the essential cores of the entire emergency management strategy. It is crucial to formulate a feasible emergency management strategy which is worth exploring. The potential risk factors in FIH, the common adverse events of innovative drugs, the key elements of first aid management and the principles of first aid management are expounded on how to realize emergency management strategies.

investigational new drugs  /  first-in-human clinical trial  /  risk management control plan  /  emergency management strategies
Ying-ying FANG, Xing-he WANG. Discussion of emergency management strategies of investigational new drugs in first-in-human clinical trial[J]. Chinese Journal of New Drugs, 2023 , 32 (22) : 2306 -2310 .
Year 2023 volume 32 Issue 22
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  • Online Date:2026-03-05
  • Published:2023-11-30
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  • Accepted:2022-10-20
Affiliations
    Phase I Clinical Trial Center, Beijing Shijitan Hospital of Capital Medical University, Beijing 100038, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
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占总种数比例
Percentage of
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Genus
种数
Number of
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占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
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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