Example 2: ADE calculation 例2：ADE计算
A teratogenic product A has a LOAEL of 1 mg/kg.day human oral dose (BW is 70 kg). Uncertainty factors applied to calculate the ADE are an UFL of 3 (extrapolation from LOAEL to NOAEL), an UFH of 10 (the inter-individual variability) and a MF of 10 (severity of effect: teratogenicity). Product B is an oral product (PK = 1).
1（mg/kg day）× 7ADE = 0kg 3×10×10×1 Result: ADEoral is 231μg/day. 结果：口服ADE值为231μg/天。
= 231（μg/day）
Example 3: Acceptance criteria based on Acceptable Daily Exposure 例3：根据可接受日暴露值计算可接受标准
Product A will be cleaned out. The product has an ADE of 2 mg and the batch size is 200 kg. The next product B has a standard daily dose of 250 mg and the batch size is 50 kg. Calculate the MACO for A in B. 产品A要被清洁，其ADE值为2mg，批量为200kg。 下一产品B标准日剂量为250mg，批量为50kg。 计算A在B中的允许最大残留量。
0.002（mg）× 50 000 000 (mMACO = g) 250 (mg) Result: MACO is 0.4g (400mg).
结果：允许最大残留值为0.4g（400mg）。
= 400(mg)
Example 4: Acceptance criteria based on Therapeutic Daily Dose 例4：根据日治疗剂量计算可接受标准
Product A will be cleaned out. The product has a standard daily dose of 10 mg and the batch size is 200 kg. The next product B has a standard daily dose of 250 mg and the batch size is 50 kg. Both A and B are administrated orally and SF is set to 1000. Calculate the MACO for A in B. 产品A要被清洁，其标准日剂量为10mg，批量为200kg。 下一产品B标准日剂量为250mg，批量为50kg。 A和B都是口服摄入，安全系数SF设定为1000。 计算A在B中的最大允许残留量MACO。
10（mg）× 50 000 000 (mg) MACO = 1000 × 250 (mg) Result: MACO is 2g (2000mg).
结果：允许最大残留值为2g（2000mg）。
= 2000(mg)