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[求助]
maximum potency的含义及来源 已有1人参与
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向各位大侠求助：“Inactive Ingredient Search for Approved Drug Products中maximum potency的含义及来源” 1) The "maximum potency" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient. (http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm) "maximum potency"是指每片（胶囊）中的最大用量，还是每天服用的最大用量？ "maximum potency"与“PDE（允许的日接触量）”或限度等概念有区别吗？ 2）以丙酮为例，检索结果如下： Search Results for: "acetone" INACTIVE INGREDIENT ROUTE;DOSAGE FORM; CAS NUMBER; UNII ;MAXIMUM POTENCY; ACETONE IMPLANTATION; PELLET 67641 1364PS73AF ACETONE ORAL; CAPSULE, ENTERIC COATED PELLETS 67641 1364PS73AF 300.504MG ACETONE ORAL; GRANULE, FOR SUSPENSION 67641 1364PS73AF ACETONE ORAL; TABLET 67641 1364PS73AF ACETONE ORAL; TABLET, COATED 67641 1364PS73AF ACETONE ORAL; TABLET, DELAYED ACTION 67641 1364PS73AF ACETONE ORAL; TABLET, EXTENDED RELEASE 67641 1364PS73AF 460MG ACETONE ORAL; TABLET, FOR SUSPENSION 67641 1364PS73AF ACETONE ORAL; TABLET, SUSTAINED ACTION 67641 1364PS73AF ACETONE ORAL-21; TABLET 67641 1364PS73AF ACETONE TOPICAL; LOTION 67641 1364PS73AF 10% ACETONE TOPICAL; SHAMPOO 67641 1364PS73AF 13% ACETONE TOPICAL; SOLUTION 67641 1364PS73AF 12.69% ACETONE SODIUM BISULFITE AN,CNBLK INTRATHECAL; INJECTION 540921 47VY054OXY ACETONE SODIUM BISULFITE AN,INFILTRATION; INJECTION 540921 47VY054OXY ACETONE SODIUM BISULFITE DENTAL; INJECTION 540921 47VY054OXY ACETONE SODIUM BISULFITE INHALATION; SOLUTION 540921 47VY054OXY 0.5003% ACETONE SODIUM BISULFITE NERVE BLOCK; INJECTION 540921 47VY054OXY 其中，丙酮的"maximum potency"可为300.504MG，或460MG或10%，远远高于“化学药物有机溶剂残留量研究技术指导原则”（PDE=50.0mg, 限度0.5%）； 这种高含量的丙酮案例是溶剂合物还是有机溶剂残留？能否检索到其对应的药品名？对仿制药研发是否有借鉴意义？ |
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3楼2020-06-08 11:44:35
【答案】应助回帖
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Maximum potency is the amount of the excipient used in the approved product that is the basis for the IID listing. The IID lists the highest amount of the excipient per unit dose in each dosage form in which it is used. The amounts shown for maximum potency do not reflect the maximum daily intake (MDI) of the excipient unless the maximum daily dose of the product that is the basis for the listing is only a single unit. For topical products and other products where excipients are expressed as a percentage of the product formula, maximum potency is the highest formula percentage. Maximum potency of an excipient is a dynamic value that changes when FDA approves products with new, higher levels of the excipient. After approval, these new maximum potencies will appear in the next publication of the IID. 重点：The amounts shown for maximum potency do not reflect the maximum daily intake (MDI) of the excipient unless the maximum daily dose of the product that is the basis for the listing is only a single unit. |
2楼2020-06-08 11:29:28