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

I would like to supplement the technical term mentioned at 31 floor above. The first time I read the term “oral cavity” is in your translation 29楼：RE:【原创】happyjyl翻译实例及解析(一), I had considered to suggest to use “mouth”, but I was not sure whether it was a technical term.  I read “oral cavity” again in this post, but when I compare the article by张震 with the English version of “Guidance for Industry Orally Disintegrating Tablets”, I found that FDA also used “mouth” (line 93 of the attached file) or “tongue” (line 44 to 46).
Guidance for Industry Orally Disintegrating Tablets

原文由 poorlittle 发表:
I would like to supplement the technical term mentioned at 31 floor above. The first time I read the term “oral cavity” is in your translation 29楼：RE:【原创】happyjyl翻译实例及解析(一), I had considered to suggest to use “mouth”, but I was not sure whether it was a technical term.  I read “oral cavity” again in this post, but when I compare the article by张震 with the English version of “Guidance for Industry Orally Disintegrating Tablets”, I found that FDA also used “mouth” (line 93 of the attached file) or “tongue”

呵呵，谢谢。这个我觉得用oral cavity和mouth都可以。oral cavity用来指口腔，在文献和说明书中等用得比较多。

原文由 happyjyl 发表:

原文由 poorlittle 发表:
SFDA technical specifications are <harmonized> generally consistent with FDA guidance in the intended uses and general requirements of ODTs <.They only differ in> except some details.

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.

用consistent with吧，这样更简洁。harmonized with更文学化，有均质的意思。

原文由 poorlittle 发表:
I would like to supplement the technical term mentioned at 31 floor above. The first time I read the term “oral cavity” is in your translation 29楼：RE:【原创】happyjyl翻译实例及解析(一), I had considered to suggest to use “mouth”, but I was not sure whether it was a technical term.  I read “oral cavity” again in this post, but when I compare the article by张震 with the English version of “Guidance for Industry Orally Disintegrating Tablets”, I found that FDA also used “mouth” (line 93 of the attached file) or “tongue” (line 44 to 46).
Guidance for Industry Orally Disintegrating Tablets

In line 79 of FDA Guidance, it is oral cavity.  To my understanding, mouth is a common term for civil English, oral cavity is the technical term for medication sicence.

developed with different technologies and formulations--这里应该用with而非by.好像with比by具体吧.

When I am not sure, I always prefer “by somebody” and “with something”  (This is a rule of thumb learnt in high school, may not be always true)

原文由 poorlittle 发表:
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.)

Totally agree.

原文由 poorlittle 发表:

developed with different technologies and formulations--这里应该用with而非by.好像with比by具体吧.

When I am not sure, I always prefer “by somebody” and “with something”  (This is a rule of thumb learnt in high school, may not be always true)

我记得中学老师说过,方法用by,仪器用with.

粗粗看了一下。觉得有必要重新置顶。献 给前面的大虾先！
由于还没有习惯说外语，大多数文字还是用中文表达。

引用：
原文:
二、FDA指导原则与我国的相关技术要求的比较
1、国内的技术要点
我国约在2001年左右出现口腔崩解片的申报，药审中心在深入讨论的基础上最终确定了如下几个质控要点：口腔崩解片的崩解时间应在1分钟内，介质首选用水，用量应小于2ml，温度37℃，崩解方法采用静态法，另外还对崩解后残渣的粒度进行了控制，要求崩解后残渣的粒度小于710μm的限度。此外，还建议同时进行志愿者人体适用性实验，以进一步确定体外崩解方法的可行性。对于难溶性药物，还要求进行溶出度的考察。

翻译:
Ⅱ Comparison of FDA guidance with SFDA technical specifications
1. SFDA technical specifications
The first application for ODTs appeared in China in around 2001. Through thorough discussion, SFDA promulgated the following key technical specifications of ODT: The disintegration time shall be within one minute. For disintegration medium , water should be the first choice .the amount of which shall be less than 2 ml,  The temperature should be at 37℃. The disintegration test method is static method . The particle size of the residue should be smaller than 710 µm. Besides, in-vivo disintegration test on volunteers should be adopted to evaluate the feasibility of the in-vitro disintegration test method. For insoluble drugs , dissolution test shall be conducted.
体外崩解方法的可行性--这里就是指体外的崩解时限测定结果能否代表药物在体内的崩解情况,所以这里还可以翻译成"体外崩解试验与体内崩解试验的相关性"(the correlation of the in-vitro disintegration test method with in-vivo disintegration method).

the amount of which shall be less than 2 ml,是否改为should? 或者简写为V≤2ml, T:37℃.
besides?直觉不对呀！

原文由 mhq111111 发表:
the amount of which shall be less than 2 ml,是否改为should? 或者简写为V≤2ml, T:37℃.
besides?直觉不对呀！

呵呵，漏网之鱼，shall应该改为should。因为这只是指导原则，没有强制所有企业照这样去做。

besides的用法没问题，茅茅姐可以看看下面的链接：
http://www.sentbase.com/default.aspx?q=besides

obviate/eliminate和ommit的区别?

“obviate” is a new word for me and I have no idea on its usage.

I also do not know the exact difference between “eliminate” and “omit”.  I generally use “eliminate” 除去 for something undesirable (such as “…to eliminate the system error in measurement…”) and use “omit”略去 for something unnecessary (such as “……the second paragraph can be omitted…”).  However, this is only my personal preference in writing, no substantiation.