Laboratory Animal and Comparative Medicine, Volume. 45, Issue 3, 331(2025)

Analysis of Common Causes of Out-of-Specification Results in the Test for Depressor Substances

TONG Xiyang, QUE Changtian, ZHANG Feng, ZHAO Lu, and WANG Hongping*
Author Affiliations
  • Safety Evaluation Center, Sichuan Institute for Drug Control (Sichuan Testing Center of Medical Devices, Sichuan Institute of Musk Deer Breeding)
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    References(5)

    [3] [3] The UK Medicines Commission. Britishpharmacopoeia 2024[M]. London: medicines and healthcare products regulatory agency, 2024.

    [4] [4] European Directorate for the Quality of Medicines and HealthCare. European pharmacopoeia supplement 11.5[M]. Strasbourg: European Directorate for the Quality of Medicines and Health Care (EDQM), 2024.

    [5] [5] World Health Organization. TRS 957 - Annex 1: WHO good practices for pharmaceutical quality control laboratories[EB/OL]. (2010-09-30) [2025-02-09]. https://www.who.int/publications/m/item/trs957-annex1.

    [6] [6] FDA Center for Drug Evaluation and Research. Investigating out-of-specification (OOS) test results for pharmaceutical production[EB/OL]. (2022-05-16) [2025-02-09]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision.

    [12] [12] YUN W J, SHIN M, JUNG S, et al. Deep reinforcement learning-based propofol infusion control for anesthesia: a feasibility study with a 3000-subject dataset[J]. Comput Biol Med, 2023, 156: 106739. DOI: 10.1016/j.compbiomed.2023.106739.

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    TONG Xiyang, QUE Changtian, ZHANG Feng, ZHAO Lu, WANG Hongping. Analysis of Common Causes of Out-of-Specification Results in the Test for Depressor Substances[J]. Laboratory Animal and Comparative Medicine, 2025, 45(3): 331

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    Paper Information

    Category:

    Received: Oct. 8, 2024

    Accepted: Aug. 26, 2025

    Published Online: Aug. 26, 2025

    The Author Email: WANG Hongping (wanghp@scidc.org.cn)

    DOI:10.12300/j.issn.1674-5817.2024.143

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