主题：【原创】happyjyl的翻译(三)--FDA发布的口腔崩解片指导原则草案及讨论

原文由 happyjyl 发表:
原文:
4、关于崩解时限要求
    关于崩解时间的限度，FDA推荐采用USP中的通用崩解仪和测定方法（动态法，且未对崩解介质的量进行限制，采用与普通片剂相同的条件），限度要求在30秒左右。我国则根据该类产品的特点，不推荐采用通用的崩解仪，方法为静态法，且根据口腔的特点对介质的用量进行了限制。从二者比较来看，我国的技术要求是根据产品的特点制定的，更具有针对性，但目前尚未实现试验设备和操作的标准化，操作也略显繁琐；FDA的要求在操作的方便性和标准化方面较好，但质控上未充分体现出口腔崩解片的特点。此外，我国的技术要求中建议进行人体志愿者试验，而FDA的指导原则中未提及志愿者体内试验。
4. Disintegration time limit(??)

The USP routine disintegrating apparatus and test method were recommended to perform disintegration time test by FDA. This is a dynamic method which does not limit the amount of disintegration medium and uses the same test conditions as common forms of tablets. The disintegration time limit is set to be approximately 30 seconds in FDA method. In comparison, SFDA does not recommend routine disintegrating apparatus, but recommends a static method which prescribes (sets) the amount of disintegration medium in consideration of characteristics of ODTs and oral cavity (口腔？？？). SFDA method is more specifc since its technical specifications were developed based on characteristic of ODTs. However, the test instrument and procedures of this relatively sophisticated method are not standardized yet. FDA guidance is more convenient and standardized, but less pertinent for ODTs.  Another difference between SFDA and FDA method lies in that SFDA recommends in-vivo disintegration test, while FDA does not.

原文由 happyjyl 发表:
原文:
关于口腔崩解片的技术要求，不同的国家目前还有差别，FDA颁布的该指导原则初稿对该类产品的开发及技术审评具有一定的参考意义，但国内申报单位在进行具体的研究时仍建议参照目前已有的技术要求和规范进行。

翻译:
Technical specifications for ODTs vary in different countries. The FDA draft guidance is a good reference for development and audition of ODTs. However, Chinese ODTs applicants are recommended to use SFDA currently recommended technical specifications and regulations while perform investigations of ODTs.

药审中心审评四部审评八室 张震

Zhang Zhen, Center for Drug Evaluation, Department Ⅳ, Room Ⅷ
quote]

In your article, 室 (or 科、股、课 etc.) means an unit in an organization.  In English, room is a space bounded with walls, floor and slab.  Therefore, please consider division, section, sub-section, group, unit etc.

原文由 ruojun 发表:

The USP routine disintegrating apparatus and test method were recommended to perform disintegration time test by FDA. This is a dynamic method which does not limit the amount of disintegration medium and uses the same test conditions as common forms of tablets.

SFDA method is more specifc since its technical specifications were developed based on characteristic of ODTs. However, the test instrument and procedures of this relatively sophisticated method are not standardized yet. FDA guidance is more convenient and standardized, but less pertinent for ODTs.  Another difference between SFDA and FDA method lies in that SFDA recommends in-vivo disintegration test, while FDA does not.

原文由 poorlittle 发表:
In your article, 室 (or 科、股、课 etc.) means an unit in an organization.  In English, room is a space bounded with walls, floor and slab.  Therefore, please consider division, section, sub-section, group, unit etc.

原文由 lianlxh 发表:
跟着学习了，虽然很多看不懂。这比那些有奖征集帖子更吸引人的眼球。只是不知论坛有多少学习药学的。