Safety
安全性
英英解釋：Practical certainty that adverse effects will not result from exposure to an agent under defined circumstances. (Ref. 2)
中文解釋：特定環(huán)境下，接觸物質(zhì)不會發(fā)生不良反應(yīng)的實(shí)際確定性。
原始出處：ICH Q3D
Safety & Tolerability
安全性和耐受性
英英解釋：The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs,clinical adverse events (diseases, signs and symptoms), and other special safety tests (e.g. ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject.
中文解釋：醫(yī)藥產(chǎn)品對醫(yī)療對象產(chǎn)生的醫(yī)療風(fēng)險(xiǎn)。通常通過實(shí)驗(yàn)室臨床試驗(yàn)（包括臨床化學(xué)和血液病學(xué)），生命體征，臨床不良事件（疾病，體征和癥狀）和其他特定的安全試驗(yàn)（如心電圖，眼科學(xué)）進(jìn)行評估。醫(yī)療產(chǎn)品的耐受性表示醫(yī)療對象對明顯不良反應(yīng)的耐受程度。
原始出處：ICH E9
Safety Assessment
安全性評估
英英解釋：An approach that focuses on the scientific understanding and measurement of chemical hazards as well as chemical exposures, and ultimately the risks associated with them. This term is often (and in this guideline) used synonymously with risk assessment. (Ref. 2)
中文解釋：對化學(xué)有害物和化學(xué)接觸，及相關(guān)最終風(fēng)險(xiǎn)的科學(xué)認(rèn)識和評估的方法。這個術(shù)語通常用作風(fēng)險(xiǎn)評估的同義詞。（Ref.2）
原始出處：ICH Q3D
Safety concern
安全性
英英解釋：An important identified risk, important potential risk, or important missing information.
中文解釋：指重大可識別風(fēng)險(xiǎn)，重大潛在風(fēng)險(xiǎn)，或缺失的重要信息
原始出處：ICH Q3D, ICH Q9
Safety Factor
安全系數(shù)
英英解釋：A composite (reductive) factor applied by the risk assessment experts to the NOAEL or other reference point,such as the benchmark dose or benchmark dose lower confidence limit, to derive a reference dose that is considered safe or without appreciable risk, such as an acceptable daily intake or tolerable daily intake (the NOAEL or other reference point is divided by the safety factor to calculate the reference dose). The value of the safety factor depends on the nature of the toxic effect, the size and type of population to be protected, and the quality of the toxicological information available. See related terms: Assessment factor, Uncertainty factor.(Ref. 2)
中文解釋：風(fēng)險(xiǎn)評估專家用于NOAEL 或其他參考點(diǎn)（如基準(zhǔn)劑量或基準(zhǔn)劑量置信下限）的一個組合（簡約）系數(shù)，以獲得一個被認(rèn)為安全或無明顯風(fēng)險(xiǎn)的參考劑量，如可接受日攝入量或每日耐受攝入量（NOAEL 或其他被安全系數(shù)劃分以計(jì)算參考劑量的參考點(diǎn)）。安全系數(shù)數(shù)值取決于毒性作用的性質(zhì)，被保護(hù)的人口的規(guī)模和類型，及可用的毒理學(xué)資料的質(zhì)量。見相關(guān)術(shù)語：風(fēng)險(xiǎn)系數(shù)，不確定系數(shù)。
原始出處：ICH Q3D
Safety Message
安全性信息
英英解釋：A safety message is an EDI message including the information provided for one/more Individual Case Safety Reports contained in one safety file exchanged between one sender and one receiver in one message transaction.[EMA]
中文解釋：安全性信息是EDI 消息，包括在信息傳輸中一個發(fā)送者和一個接收者之間交換的安全性文件中的一個/多個個例安全性報(bào)告中提供的信息個例。[EMA]
原始出處：ICH E2B(R3)
來源：電子版參閱“國際藥品注冊網(wǎng)—術(shù)語學(xué)習(xí)”
