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[求助]
maximum potency的含義及來源 已有1人參與
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向各位大俠求助：“Inactive Ingredient Search for Approved Drug Products中maximum potency的含義及來源” 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（膠囊）中的最大用量，還是每天服用的最大用量？ "maximum potency"與“PDE（允許的日接觸量）”或限度等概念有區(qū)別嗎？ 2）以丙酮為例，檢索結果如下： 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"可為300.504MG，或460MG或10%，遠遠高于“化學藥物有機溶劑殘留量研究技術指導原則”（PDE=50.0mg, 限度0.5%）； 這種高含量的丙酮案例是溶劑合物還是有機溶劑殘留？能否檢索到其對應的藥品名？對仿制藥研發(fā)是否有借鑒意義？ |
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【答案】應助回帖
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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. 重點：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樓2020-06-08 11:29:28
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