标准Ⅲ：基于健康暴露限——允许每日暴露限（PDE）的计算（根据欧盟在共享设施中生产不同药品用风险辨识建立健康暴露限度指南）CriteriaⅢ：base on health exposure limit—Permitted daily exposure (PDE) tocalculate.（EU Guidelineon setting health based exposure limits for use in risk identification in themanufacture of different medicinal products in shared facilities） | 计算公式 Calculation formula | | 说明 Statement | MACO：最大允许带入量（A产品带入后续B产品）/Maximum Allowed Carryover(Product A carrying to following Products B)(mg) PDEA：每日允许暴露量（A产品）/ Permitted Daily Exposure (mg/day) MDDB：最大日服用量(mg)（后续产品B）/Maximum Daily Dose(mg) (Product B)MBSB：最小批量（Kg）（后续产品B）/Minimum Batch Size（Kg）(Product B) | 计算公式 Calculation formula | | PDE = | NOEL × BW | | F1 ×F2 ×F3 ×F4 ×F5 |
| | 说明 Statement | NOAEL无可见有害影响水平 No Observed Adverse Effect Level (mg/kg/day) BW :平均成人体重/Is the weight of an average adult (e.g. 50 kg) F1~F5：安全因子（安全因子F1到F5选择，可以参考ICH Q3C的相关内容 ） F1~F5：safety factor (select safety factor from F1 to F5, related content of ICH Q3C can be referred to) | PDE计算公式中，NOAEL的检索应基于科学的方法并制定相应的策略。检索策略、检索记录和结果均应该记录，并应由相关的主题专家（SME）进行审核。安全因子选择同样应基于原料药的毒理数据并由相关的主题专家进行评估。 In PDE calculation formula, searching of NOAEL shall be based on scientific method and corresponding strategy shall be drafted. Searching strategy, searching record and result shall be documented and then reviewed by related Subject Experts (SME). Selection of safety factor shall be based on toxicology data of API also and then evaluated by related SME. d. 该方法不适用于以下情况： e. This method is not applicable to the following situation: ——基因毒性（有诱变）对人类致癌的。 Genotoxic (specifically mutagenic) compounds, carcinogenic to humans. ——低剂量即可以产生生殖反应和/或发育反应的化合物 Compounds that can produce reproductive and/or developmental effects at low dosages. ——低剂量即可能会导致目标器官严重毒性，或其它重大不良反应的化合物。
Compounds that can produce serious target organ toxicity or other significant adverse effects at low doses; ——具有高药效的化合物，即，建议日剂量<1 mg (兽药剂量等于0.02mg/kg)。
Compounds with a high pharmacological potency i.e. recommended daily dose of <1mg (veterinary dose equivalent 0.02 mg/kg). ——具有高致敏可能性的化合物。 Compounds with a high sensitizing potential. |
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发表于 2022-8-25 14:43:40
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