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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Aquaculture Specialist Puts ‘PhishPharm’ Database of Drug Studies in Aquaculture on Internet

FDA Veterinarian Newsletter September/October 2005 Volume XX, No V

Center for Veterinary Medicine (CVM) aquaculture specialist Dr. Renate Reimschuessel has created a database, which she has named “PhishPharm,” of studies about drug metabolism in aquaculture species and made the database available to researchers and others via the Internet. It contains 400 studies now, and will be expanded as additional studies and data become available. As explained in this interview, Dr. Reimschuessel invites users to submit reports of published studies to be included in the database.

FDA Veterinarian: What is “PhishPharm?”

Dr. Reimschuessel: It’s a database, originally designed to help me organize a massive literature search, that has developed into a tool that I use frequently when designing experiments. It should also prove very helpful as a source of information for the CVM aquaculture drugs review team and other regulatory scientists. I hope it will be useful to scientists working on drug development for aquatic species both in the United States and abroad.

FDA Veterinarian: What prompted you to develop this database?

Dr. Reimschuessel: CVM held a meeting August 30, 2000, titled “Crop Grouping in Aquaculture.” At this meeting, research scientists from Upper Mississippi Environmental Sciences Center, Virginia-Maryland Regional College of Veterinary Medicine, the NRSP-7 (National Research Support Project #7) program, and The Ohio State University presented CVM with data about grouping species for drug approvals. Pharmacokinetic data for several drugs in several fish species were presented. It was clear, though, that much more data were needed to understand how, and at what rates, different fish species metabolize drugs. One of the first steps needed was to compile existing data.   FDA Veterinarian: Is there that much information available about fish?

Dr. Reimschuessel: In general it was assumed that “there is not much known” about fish pharmacokinetics. This assumption is both true and false. Compared with mammalian pharmacokinetics data, there is much less information available for fish. Nevertheless, there is still a wealth of information that has been published over the last 30 years. Unfortunately, this information is located in journals that are fairly specialized and not readily available from an average search of databases, such as MEDLINE.

In order to become more knowledgeable in this area, I began to collect as many articles as possible about drug metabolism and residue depletion in fish. After about 2 years of collecting, I had a stack of about 150 articles in my office and would spend quite a bit of time trying to find specific information that I knew was in one of those articles. I decided it was necessary to begin to mine data from these articles, if only by species, by compound tested, and by the citation. I began putting this information into an excel spreadsheet. (Over the summers I would enlist the help of student interns to help mine more of the data from these articles.)

However, I found that besides the information I had started to gather I wanted to know the dose of the compound and how long it was administered. Then I wanted to know at what temperature the fish were held, and if they were in saltwater or freshwater. Later the weight of the animals was added along with more extensive comments on residue levels over time.

Gathering this information took many months and many hours. The spreadsheet grew until it was more than 800 rows long, and again I was faced with something that was getting unmanageable. I could not find the information buried in such a long sheet.

FDA Veterinarian: How did the spreadsheet become the database?

Dr. Reimschuessel: In 2003, I teamed up with Clifford Hodsdon, an independent programmer (contact information is in the PhishPharm database), to convert the data from spreadsheet format into an Access database. With the first iteration it became quite apparent that we needed major revisions in the way we presented the information. All of the data needed to be put into standardized formats for the database program to work. For example, all the weight data that students had put into the database were in the format used in the original articles (pounds, grams, kilograms, etc.) and had to be converted to a standardized format. The same was true for quite a number of fields.

Thus began the long and arduous task of re-working the mined data to get them into formats that the database would be able to sort and provide back in a meaningful form.

Also, over the next two years, with the help of the CVM librarian Debbie Brooks, the list of articles grew to more than 400. The number of fields and amount of details mined from the articles also grew.

It was about this time that the goal of organizing this material for my own use changed to one of developing a publishable database so others would be able to benefit from our efforts.

This new goal meant that the database entries needed to be proofread multiple times by several different people to ensure accuracy.

FDA Veterinarian: When did you first post the database?

Dr. Reimschuessel: We posted it in October 2005, so it’s relatively new.

FDA Veterinarian: How often will it be updated?

Dr. Reimschuessel: We plan to update the information yearly.

FDA Veterinarian: Have you disseminated information about the database?

Dr. Reimschuessel: Our group published an article for American Association of Pharmaceutical Scientists (AAPS) (Reimschuessel R, Stewart L, Squibb E, Hirokawa K, Brady T, Brooks D, Shaikh B, Hodsdon C. Fish Drug Analysis—Phish-Pharm: A Searchable Database of Pharmacokinetics Data in Fish. American Association of Pharmaceutical Scientists Journal 07(02): E288-E327 2005 http://www.aapsj.org/view.asp?art=aapsj070230) that used the database to produce a number of graphs that show the half-lives of different drugs in different fish species.

(The database is accessible through this article. Use the link to go to the article, and scroll down through the article to the “zip” links to the database.)

The type of data available through the database for the first time allows us to begin to look at the forest rather than the individual trees. With the information summarized in such a fashion, one can get an overview of the kind of data to expect and how much variability one should expect with a given compound. For example, it was not possible for me to appreciate the metabolic similarity between the many fish species without this kind of data presentation.

FDA Veterinarian: How can someone find out more?

Dr. Reimschuessel: The database is available to be downloaded from the AAPS website. It is an Access database, but it has also been put into a stand alone Application format for users that do not have Access on their computers. I have also made the raw data Excel spreadsheet available for users that would like to be able to view that format.

To access the database, go to http://www.aapsj.org/view.asp?art=aapsj070230 and scroll down to the zip links.