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出自识林

2015-01-08 识林

FDA网站指南页面出现了新的搜索功能url。该搜索允许在几个FDA所谓的“专题区”中搜索指南。有机会使用过FDA一般搜索功能url 的用户知道其搜索结果的不尽如人意。常常会返回数千条不相关的参考资料。看起来无论如何精心设计查询，结果都是没用的，似乎总是缺少最明显的文件。

现在FDA的一个很好的新功能就是在新指南发布或修订时，会给出相关其它指南的列表。这是极其有帮助的，我非常赞赏FDA的这一行动。这节省了搜索的大量重复时间（如果你想手动获得正确答案），确保您已经找到相关指南。所以欢迎这一新的自动指南搜索功能，至少我报以极大期待。

为了测试这一新功能，我选择了搜索与药品（人用药）批准后变更相关的指南。当人们考虑做批准后变更并希望查到需要的支持性数据，该搜索是最常用的搜索之一。这里有几个相关的指南有助于对批准后变更的支持性数据和提交分类做出决定。这些指南是：

• “已获批的NDA或ANDA的变更”
• “已获批的NDA或ANDA的变更—问答”
• “CMC批准后生产变更在年报中记录”
• 还有一些所谓的SUPAC指南，SUPAC IR、SUPAC MR、SUPAC SS以及设备附录。还有关于分析实验室变更的PAC ATLS，对于一些人可能也是需要的。

此外，这是一个很好的搜索词，因为FDA既使用“post-approval”，也使用“postapproval”。我不认为他们使用“post approval”，但可能作为术语使用。FDA其它的搜索功能似乎会严格按照字面意思搜索，即搜索“post-approval”将不会识别“postapproval”或“post approval”。

如果你感兴趣的是人用药，可以通过至少2种方式进入新的搜索url，但是我肯定在FDA网站的其它专题区还会有其它链接可以进入。正如我们将看到的，你从何种入口进入搜索变得非常重要。

第一种方式是去FDA主页www.fda.gov。页面底部左侧有一栏“监管信息（Regulatory Information）”，题目下面的第一条是“指南文件（Guidance Documents）”。点击此标题，弹出的页面带有简短的前言，同时下面有一个题为“搜索所有指南文件”的搜索框。在搜索框中输入“post approval changes”,得到6条结果，出人意料的是，所有指南从标题看除一条外均是与人用药相关的指南。其中有3条SUPAC指南、PAC-ALTS和年报变更。然而没有获得最重要的指南—变更指南。接下来我试着使用“post-approval changes”作为我的搜索词，其中使用了连字符。这使事情变得更加糟糕，我仅得到2条结果，SUPAC IR和SUPAC SS。接下来我又试用“postapproval changes”作为搜索词。得到4条结果，SUPAC MR、PAC-ALTS、年报变更和不相关的CVM BACPAC指南（GFI#126）。

好消息是搜索结果直接指向指南，而且没有多余的文本提到其它文件。坏消息是FDA并不使用的术语“post approval”得到最相关的搜索结果，但还是丢失了最终要的指南，而FDA合理使用的术语“post-approval”和“postapproval”却不能搜索得到相关的指南。我不明白这些看似非常相似的搜索词之间产生这些奇怪结果的逻辑。如果给搜索词加引号的话结果会比想象的更糟糕，因为这会强制按照词的字面形式搜索。

总体而言，这些搜索结果比FDA之前的搜索要好，但是比使用FDA网站外部的Google搜索要差。当在Google上使用同样的3个搜索词搜索（没有提及FDA）时，返回的结果是最相关的而且在最前面的几条结果中包括“变更”指南。

上述结果是由www.fda.gov主页上的链接搜索得到的，而且没有指定专题区，即没有指定我们感兴趣的药品数据。如果你从www.fda.gov进入点击“药品”通过主题浏览指南文件，您会进入www.fda.gov/drugs版本的指南页面。页面顶部有一个搜索框，框中（灰色字体）写着“搜索药品和疫苗，血液和生物制品指南部分”。输入我们的搜索词“post approval changes”得到383条结果，几乎所有结果是3个字分开的文本内容。另外，文件题目不包括在内，除非搜索内容在题目中出现，如果浏览一下最前面的几页结果会发现得到的最相关的指南包括“变更”指南。搜索“post-approval changes”得到8830条结果，还是来自于文本搜索，结果中还是包含大多数最相关的指南。搜索“postapproval changes”得到2030条结果，相关性较低的指南出现在前面。从这个位置搜索的问题是文本搜索，而且从www.fda.gov入口进入并不是搜索的指南文件。

这里描述的搜索功能仅是从www.fda.gov进入，而且仅是针对所有指南文件的一般性搜索。试图将搜索范围缩小到”Drugs”会进入另外一个具有不同功能的页面。 搜索指南的关注点是，确保能找到所有相关指南。不幸的是，尽管新的搜索功能可以找到许多相关指南，而且非常重要的是针对指南文件的搜索，并且不是文本搜索。但并不能找到所有指南。总之，有一定帮助但并不能取代完整搜索。

尽管我欢迎并鼓励FDA改善网站搜索功能的努力，但似乎应多一些测试。对“post approval changes”的一般性Google搜索得到的最前面的3条结果是三份最重要的指南。将这一Google搜索缩小至www.fda.gov区域后，最前面的20条搜索结果得到所有相关的（药品）指南文件。

北京大学药物信息与工程研究中心 - Garth Boehm博士 2015-01-06
校译：识林-椒 2015-01-07

A new Search Function for Guidances
Written by Garth Boehm January 06, 2015

A new Search function has appeared in the Guidances page of FDA's websiteurl. This search allows searching of guidances in several of FDA's so-called “program areas”. Now those of you who have had occasion to use FDA's general search function url will know that it is less than satisfactory. It often returns thousands of always irrelevant references. It seems that no matter how carefully you design your query, the results are useless, always it seems missing the most obvious documents.

Now lately in an excellent new feature FDA has been giving a list of other relevant guidances when new guidances are issued or revised. This is extremely helpful and I congratulate the Agency on this initiative. It saves countless repetitive hours of searching (manually if you want the correct answers) to be sure that you have located all relevant guidances. So this new automated guidance search function is greeted, at least by me, with great anticipation.

In order to try out this new function I chose to search for Guidances that are relevant to post approval changes for drugs (human drugs that is). This search is one of the most requested when people are thinking of making post approval changes and want to work out what is expected as supporting data. There are several relevant guidances that contribute to deciding on the support data and filing classification for post approval changes. These are:

• “Changes to an Approved NDA or ANDA”
• “Changes to an Approved NDA or ANDA – Questions and Answers”
• “CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports”
• These are followed by the so-called SUPAC guidances, SUPAC IR, SUPAC MR, SUPAC SS, and the Equipment Addendum. Then there is also the PAC ATLS for analytical laboratory changes and there may be a need for others.

In addition, this is a good search because FDA uses both post-approval and postapproval . I do not think they use post approval, but it could be used as a term. FDA's other search functions seem to be rigidly literal in interpreting search terms, that is a search for post-approval will not recognize postapproval or post approval.

Now you can get to this new search in at least 2 ways if your interest is human drugs, but I am sure there are other links within other program area parts of FDA's website. It turn out to be very important how you get to the search as we will see.

The first way is to go to FDA's Home Page, that is www.fda.gov. Near the bottom of this page on the left hand side is a box headed “Regulatory Information” and the first entry under this heading is “Guidance Documents”. Click this heading and a page appears with a short preamble followed by a search window titled “Search All Guidance Documents”. If you type in post approval changes you get 6 results, all guidances by title and all but one, somewhat surprisingly, relevant guidances for human drugs. These are the 3 SUPAC’s, the PAC-ALTS, and the Annual Report changes. However you do not get the most important guidance, the Changes guidance. Next I tried post-approval changes as my search term now using the hyphen. This made things worse, I only got 2 results, the SUPAC IR and SUPAC SS. Next I tried postapproval changes as the search term. That returned 4 results, SUPAC MR, PAC-ALTS, the Annual Reportable Changes and the irrelevant CVM BACPAC guidance (GFI #126).

So the good news is that it was pointing me to guidances and not text mentions in other documents. The bad news is that post approval, the term FDA does not use was most relevant but still missed the most important guidances, and post-approval and postapproval, the terms FDA does use faired significantly worse in pointing to relevant guidances. I do not understand the logic that leads to these strange results between these seemingly very similar search terms. Including quotes around the term made things worse as might be expected since this should force a literal for the term. Overall these results were better than FDA's previous search but worse than using a Google search from outside of FDA's website. When exactly the same 3 search terms were used (without reference to FDA), the results returned were more relevant and included the “Changes” guidance in the first few results.

The results obtained as described above were obtained by searching from the link contained on the www.fda.gov home page and without specifying a program area, that is without specifying that it is the Drugs program that we are interested in. This is where things got rapidly worse. If you go to the search from www.fda.gov and click on Drugs under Browse Guidance Documents By Topic you are taken to the www.fda.gov/drugs version of the Guidance Page. This has a search box at the top which says (in greyed out type) Search the Drugs and Vaccines, Blood & Biologics Guidances Section. If you enter our search term post approval changes you get 383 results, almost all of which are from a text search of the three words separately. Also the title of the document is not included unless the text is in the title, however if you go through the first few pages it does return most of the relevant guidances including the “Changes” guidance. Search of post-approval changes returned 8830 results, again from a text search and again containing most of the relevant guidances within the results. Search of postapproval changes returned 2030 results with less of the relevant guidances up front. The problem with searching from this position is that the search is a text search and NOT a search of Guidance Documents which you do get from the entry point www.fda.gov.

The search function described works ONLY from the www.fda.gov entry point and only for a general search of all guidance documents. Attempts to narrow the search to say Drugs takes you to another page which does not have the same functionality.

The issue when searching for guidances is to be sure you have found all the relevant guidances. Unfortunately while this new search function does find many of the relevant guidances, and very importantly is a guidance document search and not a text search, it does not find them all. Conclusion, it helps but does not substitute for a complete search.

While I welcome and encourage the effort to improve FDA's website search capability, a little more beta testing would seem to be in order. A general Google search of post approval changes returns the 3 most important guidances as the first 3 results. Narrowing this Google search to the domain www.fda.gov produces all the relevant guidance documents (for drugs) within the first 20 search results.

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