中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2015年
2期
141-146
,共6页
药物非临床安全性评价%供试品相关问题%影响因素
藥物非臨床安全性評價%供試品相關問題%影響因素
약물비림상안전성평개%공시품상관문제%영향인소
non-clinical safety evaluation%issues related to test articles%inlfuencing factors
目的：促进供试品有效管理，避免新药研发过程中不必要的失误和损失。方法：通过自身工作实践及同行交流，对主要影响药物非临床安全性评价的供试品相关问题及因素进行梳理和总结。结果：从不同角度揭示了影响药物安全性评价的供试品相关问题。结论：只有全面重视供试品管理中各个环节的问题，并不断提高和完善，才能真正保障新药安全性评价结果的准确和可靠。
目的：促進供試品有效管理，避免新藥研髮過程中不必要的失誤和損失。方法：通過自身工作實踐及同行交流，對主要影響藥物非臨床安全性評價的供試品相關問題及因素進行梳理和總結。結果：從不同角度揭示瞭影響藥物安全性評價的供試品相關問題。結論：隻有全麵重視供試品管理中各箇環節的問題，併不斷提高和完善，纔能真正保障新藥安全性評價結果的準確和可靠。
목적：촉진공시품유효관리，피면신약연발과정중불필요적실오화손실。방법：통과자신공작실천급동행교류，대주요영향약물비림상안전성평개적공시품상관문제급인소진행소리화총결。결과：종불동각도게시료영향약물안전성평개적공시품상관문제。결론：지유전면중시공시품관리중각개배절적문제，병불단제고화완선，재능진정보장신약안전성평개결과적준학화가고。
Objective:To promote the effective management of test articles to avoid unnecessary mistakes and losses in the process of new drug research and development. Methods:Based on work experience and peer exchanges, the main issues related to test articles and inlfuencing factors in non-clinical safety evaluation were summarized and sorted.Results:In this paper, the influence of issues related to test articles and influencing factors in drug safety evaluation were revealed from different aspects.Conclusion:Only by attaching importance to the problems in all links of test article management and constantly improving the management, can the accuracy and reliability of results of non-clinical safety evaluation be guaranteed.
