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标题:[未解决]【求助】IIG最大使用量何解????

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small2011[使用道具]
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【求助】IIG最大使用量何解????

园子里的高手们,请问一下,FDA中非活性成分最大用量(IIG)指的是单剂量的最大用量还是每日的最大摄入量?谢谢!
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jom[使用道具]
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看看FDA药物非活性成分数据库关于“MAXIMUM POTENCY”的说明你就明白了。


Inactive Ingredient Field Descriptions



Inactive Ingredient An inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug products are included in this database.



Route A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the Data Standards Manual.



Dosage Form A dosage form is a form in which a drug is produced and dispensed. A comprehensive list of specific routes of administration appears in the Data Standards Manual.



CAS Number The acronym "CAS" stands for "Chemical Abstracts Service," a division of the American Chemical Society that provides comprehensive electronic chemical information services. CAS assigns unique CAS Registry Numbers to chemical substances. Many inactive ingredients have CAS Registry Numbers, which are useful in searching other databases for chemical information. The CAS Registry Number itself has no chemical significance.



Maximum Potency The "maximum potency" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient.

由此可以看出这是每个给药途径的单剂量所含的非活性成分。



When there is no calculable potency measurement for the inactive ingredient, the "maximum potency" field will be blank. UNII The acronym “UNII” stands for “Unique Ingredient Identifier”



The UNII is a part of the joint USP/FDA Substance Registration System (SRS), which has been designed to support health information technology initiatives by providing unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information. The SRS is used to generate permanent, unique, unambiguous identifiers for substances in regulated products, such as ingredients in drug products.



More information about the UNII and the SRS is available on the Data Council SRS page. All chemically-related questions about the UNII or the SRS that are not answered on the FDA website should be directed fda-srs@fda.hhs.gov.
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非常感谢!!!
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是按处方量吧...而实际上,操作起来有些难度。
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