[quote]原文由 happyjyl 发表:[quote]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.

Division,在行政上比较大，有点“处“级的意思, Division Chief就是处长了；
Section,一般就是科、室，日本韩国人称课，中国称股，Section Chief就是科长了；
Group,指一个研究或工作小组，
Unit,单元、单位，长指一个大的单位，如农业部、卫生部、学校。
所以这儿的部就翻译为Division, 室就翻译为Section吧。我也没看就给你留了，改个顺序而已。

Sorry, slab should be amended to ceiling.
In the organization I am working for, unit and group are similar and under section, while section is under division.

Unit如果是单元的意思是，应该与Group相似。如果讲中国的一个组织单位organization or unit又相似了。不过unit的确代表小单元的地方多。

看到大家的讨论.不错呀.

Ⅱ Comparison of FDA guidance with SFDA technical specifications
1. SFDA technical specifications
The first application for ODTs in China was submitted [1] in around 2001. After thorough discussion, SFDA defined [2] the following key technical specifications of ODT: [3]
- The disintegration time shall [4] be within one minute;
- Water is the first choice for disintegration medium, which shall be 37℃ and less than 2 ml;
- The disintegration is by means of static method;
- The particle size of the residue shall be smaller than 710 μm;
Besides, in-vivo disintegration test on volunteers should [5] be adopted to determine [6] the feasibility of the in-vitro disintegration test method. For insoluble drugs, dissolution test shall be conducted.

[1] “The first application for ODTs appeared in China in about 2001” might be interpreted as约在2001年左右, ODTs 开始在中国应用 especially if “for” is replaced with “of”.
[2] or promulgated (for the organization with authority).
[3] Sometimes, changing to point form may improve the readability. But some translators object any change to the format of the original.
[4] “Shall” is generally for mandatory (refer to GB, ASTM, ISO etc.) Does the original mean mandatory?
[5] “Should” is generally for advisory (the original used the word 建议)
[6] or verify, evaluate, study

Suggested alternative: (words in < > are to be deleted)

2. Tablet weight
SFDA technical specifications are generally consistent with FDA guidance in the intended uses and general requirements of ODTs <.They only differ in> except some details. For example, FDA recommends that the tablet weight [shall] be less than 500 mg. In SFDA , even it has been agreed that the tablet weight should be as low as possible, but there is no restriction on the tablet weight as the particle size of the residue after disintegration would been controlled. The necessity of imposing restriction on the tablet weight is still under discussion.

(How to change the style of fonts in the post? (bold, colour, underline, crossing out etc.)

我只知道如何编辑彩色文字:在中插入文字,这部分文字就会变成红色.想用其它颜色显示的话可以把red替换成blue,yellow等等.

请教:harmonized with和consistent with有什么区别呢?都可以表示"一致"的意思.而且USP在介绍各种通用的测定法时会写明本方法harmonized with英国药典或日本药典中的方法.

非常感谢poorlittle和ruojun的指教!已按你们的建议对有关部分进行了修改,用红色标注出来了.欢迎就剩余的部分继续讨论.

Sorry, I do not know that “harmonized” is a technical term in the field of pharmaceutics. I understand , with the experience in my profession, that a term commonly used in a field may has special implied meaning (not the meaning in ordinary dictionary) or just a tradition without special meaning, 只可意会不可言传.

(I suggested “consistent” simply because it is a very common term. I still follow the advice given by my English teacher in high school that when you finish a draft, you should do two things: (1) Cut 20% to 50% of words; (2) Change the uncommon words and compound sentences into simple words and simple sentences as far as possible.)