Author(s)

Guiyu Liu ¹

Affiliation(s)

¹ Alpha Gen Therapeutics, Pudong, Shanghai, 201399, China

Corresponding Author

Guiyu Liu

ABSTRACT

Non-clinical trial of drugs is a key link in drug research and development, and its quality control directly affects the safety and effectiveness evaluation of drugs. At present, non-clinical drug trials are faced with many quality control problems, such as imperfect design of trial scheme, nonstandard operation of personnel, improper management of instruments and equipment, chaotic data recording and management, and ineffective implementation of quality assurance system, which may lead to deviation of test results and even failure of drug research and development. In this paper, the main problems existing in the quality control of drug non-clinical trial items are deeply analyzed, and the corresponding improvement countermeasures are put forward from the aspects of optimizing the design of test scheme, standardizing the test operation process, improving data management and recording, strengthening the quality assurance system and strengthening external cooperation and communication. Through these measures, we can effectively improve the quality control level of drug non-clinical trials, ensure the scientificity, accuracy and repeatability of test results, lay a solid foundation for drug research and development, and promote the healthy development of pharmaceutical industry.

KEYWORDS

Quality Control; Countermeasures; Drug Non-Clinical Trial Items

CITE THIS PAPER

Guiyu Liu, Problems and Countermeasures of Quality Control of Drug Non-Clinical Trial Items. Social Medicine and Health Management (2025) Vol. 6: 1-8. DOI: http://dx.doi.org/10.23977/socmhm.2025.060201.

REFERENCES

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[4] Tan Qin, Li Qingna, Xiao Mengli, Ying Jiako, Zhao Mengjie, & Ji Jinjin et al. (2024). Discussion on the Issues and Solutions in the Design of Clinical Trials for New Traditional Chinese Medicine from a Quality Control Perspective. Chinese Journal of New Drugs, 33(8), 805–809.
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