FDA有个非活性物质数据库，每种给药途径对应的辅料都有日最大使用剂量。如果超过最大使用剂量，也就是IID(以前叫IIG）就得做安全性研究。我问过这个问题，药监局给的建议是尽量不要超过，如果实在需要超过IID，可以 ...
你好，FDA得给活性数据库你确定是日最大使用量吗？？？我看FDA数据库解释，理解应该是单片剂量的意思吧
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.
