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Sources of information for pharmaceutical translators

Warning 1: This deals with the situation in the United States and with 'American' terminology.

Warning 2: Translation of pharmaceutical documents generally requires a fairly good background in chemistry, sometimes microbiology, occasionally both; and often some medicine. This will not substitute for that.

Warning 3: This was written in the middle of 2002, and I may well have missed some changes before that.

Advice 1: You might be asked to convert metric (SI) quantities to some "English" system (drams, minims, grains, etc.). Resist! US laboratories essentially universally use metric/SI units. If there are still any production procedures using "English" units, they will probably not be able to use your conversions directly anyway, because of inconvenient quantities. For instance, 500 liters of water would become approximately 132.086 US gallons, or 109.9845 British gallons. The manufacturer would probably convert the entire formulation to use either 100, 125, or 150 gallons.

All the major countries have developed extensive sets of laws and regulations dealing with pharmaceuticals. Those are materials once called 'drugs' before that term was widely understood to mean 'illegal drugs'. In the US, 'drugs' for medical purposes have been regulated under the 1906 Pure Food and Drugs Act and, more recently, the Food, Drug and Cosmetic (FD&C) Act of 1938, with later changes. The law is enforced by the Food and Drug Administration (FDA), which has the power to propose regulations that are published in the daily Federal Register. The proposed regulations are discussed, and may eventually be adopted, often in modified form. The final versions are published again in the Federal Register, after which they are effectively law. They are subsequently published in the next edition of Title 21, Code of Federal Regulations (21CFR). (Illegal 'drugs' are the responsibility of the Drug Enforcement Agency (DEA).

All of that legal and regulatory information is available to translators, but usually not useful for technical translators.

The Federal Register (published daily) is a collection of all proposals, changes, etc., about any subject which the federal government regulates. Merely reading it is more than a full-time job; people read only the parts of direct interest to them.

The Code of Federal Regulations is basically about the details of the law. 21CFR does get into some technical details, but very few; and I can't recommend it for technical translators, though it will certainly give a taste of "federalese". New printed versions of 21CFR appear every two years. The last edition that I have seen (April 2000) was in 9 unindexed volumes of small print, and cost more than $200. A pair of CD-ROMs containing the entire CFR (50 titles) is available from Solutions Software Corporation (solution@env-sol.com/ at $250). If you must get information from CFR, though, it is probably more practical to do an on-line search at:


If you are much involved with pharmaceutical law and regulation, consider one of the books which attempt to provide explanations. Law and regulations make the United States Pharmacopeia (USP) binding on pharmaceuticals in the US. The USP defines and specifies raw materials and finished products. For instance, it specifies that a particular tablet must contain from 90% to 110% of the labeled amount of the active ingredient(s), and specified certain tests which the product must pass. A related publication, the National Formulary (NF) was once independent but is now published in a single volume with USP. The current volume is USP 30 / NF 25. If you need to use USP, note some potential problems:

  • References are often to section numbers. For instance, USP 23 <171> is the procedure for microbioassay of Vitamin B12 activity, in Section 171 on pages 1719 - 1721.

  • The index is (in my opinion) not as good as it might be. USP contains information which is difficult to find in the index. For instance, I do not find 'acetylsalicylic acid' in the index, even though it is a common term for 'Aspirin'.

  • There will be numerous listings ("monographs") for many active ingredients. For instance, I find, in USP 23, a monograph for Aspirin as a raw material, and 28 monographs on specific products, such as "Aspirin, caffeine and dihydrocodeine bitartrate capsules".

  • Supplements to USP/NF are published regularly, and they may add, change, or delete monographs, test specifications, etc.

  • Your document may refer to monographs, procedures, etc., which appear in earlier editions of USP/NF and are no longer 'official'. Also, of course, it may refer to procedures which are not in a pharmacopeia at all.
Note, too, that the current edition sells for $715 from the US Pharmacopeial Commission. In my opinion, it has some information perhaps useful to translators in specific cases (for instance, if you need to know just how a dissolution test is done), but I cannot recommend it, especially at its price. I have the previous edition (USP23/NF18) from when I was actually working in the field, and you may be able to find a copy of that edition, very nearly as useful, at a tolerable price.

Fortunately, there are publications which are useful and more or less reasonably priced:

Remington: The Science and Practice of Pharmacy. A. R. Gennaro, Editor. Lippincott, Williams and Wilkins, 2005: $135. I consider Remington the best single reference in English, even though the first part is a review of chemistry. I have the 19th Edition, which was accompanied by the CD-ROM version. In that edition, Chapter 7 presents many other sources of information.

The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals , 2006. Available from Merck & Co., Whitehouse Station, New Jersey. ($125). Note that this is not the same as the Merck Manual, which is about diagnosis and treatment. Most of the Merck Index consists of listings of over 10,000 chemicals of pharmaceutical importance, with chemical names, trade names, and chemical information. Even more useful for translators though, are:

  • 360 pages of index, with cross-referencing of trade names and abbreviations

  • 6 pages of abbreviations and definitions

  • 5 pages of a rather basic glossary

  • 2 pages of lists of abbreviated names of chemical groups e. g.: xinafoate = 1-hydroxy-2-naphthalenecarboxylate

  • Latin terms found in prescriptions (translated into English)

  • conversion factors

  • perhaps also 64 pages of identification of chemicals by their Chemical Abstracts Service Reference Numbers.

The Merck Manual , 18th Edition, $43. Not particularly pharmaceutical, but a useful condensed medical reference.

USP Dictionary. US Pharmacopeial Convention. US adopted names and international drug names. The current edition is $299. I find the Merck Index a better buy, though the USP dictionary may have some listings that the Merck Index does not.

Physician's Desk Reference (PDR). Published annually by Medical Economics Company. ($95) Widely available at bookstores, with older editions (nearly as useful) at used book stores. A useful guide to US English technical writing about prescription drugs, including indications, counterindications, adverse effects, etc.

Rote Liste. Published annually by Bundesverband der Pharmazeutischen Industrie e. V., Editio Cantor Verlag für Medizin und Naturwissenschaften GmbH, Postfach 1255, 7960 Aulendorf/Württ. I last saw this listed at DM 120. It is a listing of products made by companies in the Bundesverband: tradenames, ingredients, etc.

Various dictionaries: This listing is biased because I work only from German to English. There are few if any bilingual dictionaries for pharmacology and pharmaceuticals. Translators must usually rely on medical and chemical dictionaries, such as:

Pschyrembel Klinisches Wörterbuch. (about $42)
Wörterbuch Medizin, F.-J. Nöhring, Ed. German <>English
     Langenscheidt and Routledge, 2001.

Roche Lexikon Medizin (German), Hoffman LaRoche

Der Große Reuter. Springer Universalwörterbuch Medizin, Pharmakologie und Zahnmedizin. Deutsch-Englisch/Englisch-Deutsch (Springer-Wörterbuch)

Compact Euro-Wörterbuch Medizin Pharmazie. Compact Verlag, München, 1997.
     German, English, French, Italian, Spanish. Useful, though limited.

Dorland's Medical Dictionary, Saunders, about $43.

Fachwörterbuch medizinische Laboratoriumsdiagnostik, U. Spranger and J. Grové, Verlag Alexandre Hatier, 1993 (DM 198) German - English - French

Lexikon medizinisch-wissenschaftlicher Abkürzungen., R. Heister. Schattauer Verlag, 4th Ed., 1998. German.

Stedman's Abbrev: Abbreviations, Acronyms & Symbols W. R. Hensyl, Ed., Williams and Wilkins, 2003 (English; medical)

German to English Dictionary of Chemistry / Woerterbuch Chemie Deutsch - Englisch, G. Wenske, VCH, 1994 (German > English)

Fachwoerterbuch Chemie und Chemische Technik Englisch - Deutsch(German > English). (Borsdorf, Gross, Knepper, Eds.). Verlag Alexandre Hatier.

Other reference books:

See, for example, the catalog from Interpharm Press, 15 Inverness Way East, Englewood CO 80112; www.interpharm.com. These specialized books have a relatively small market, which makes them relatively expensive (and they appear to mark up prices of some books available elsewhere). One which I have not yet seen is "FDA-Speak", A glossary and agency guide; 2d edition; 369 pages at $199(!). Most of their books are rather specialized, but you may find something that is just what you need. (For instance: "Protein Formulation and Delivery", E. J. McNally, Ed., 278 pages, $150.)

Catalogs: various suppliers publish chemical catalogs. They are generally not bilingual, but one or more of them may help you confirm that there really is a chemical by the name which you have just translated.
The most useful (again, in my opinion) are the Sigma catalog (biochemicals) and the Aldrich catalog (organic chemicals), both published by Sigma/Aldrich (www.sigma-aldrich.com). Sigma: P. O. Box 14508, St. Louis MO 63178. Aldrich: P. O. Box 355, Milwaukee WI 53201. In the past, both Sigma and Aldrich have offered catalogs for $25. You may be able to get old catalogs (still useful) from a college or industrial laboratory. Try for an old catalog of laboratory equipment, too (e. g., the Fisher, Sargent, or VWR catalog).
Some specialized pharmaceutical testing equipment is made by Vankel (13000 Weston Parkway, Cary NC 27513-2228). They have a catalog, but the information on their web site may serve equally well (www.vankel.com).

Magazines: Scientific journals are generally not useful enough to a translator to justify their very high prices or the time spent reading them. There are several 'controlled circulation' magazines that are sent free to people in the pharmaceutical industry, and translators for the industry probably qualify. Subscriptions are available, but sometimes expensive. Most of them are on line (free); see the URLs below.

Pharmaceutical Technology. Published by Advanstar Communications, Inc., 131 West First Street, Duluth, MN 55802-2065. An excellent source of current information about the pharmaceutical industry, and about US FDA requirements and new regulations. You may even find the advertisements informative. If you deal with pharmaceutical regulation, you will probably profit from the monthly article by Jill Wechsler.

Biopharm International. Also by Advanstar. This is a specialized biotech version of Pharmaceutical Technology. The printed monthly copies are often accompanied by very informative supplements. Jill Wechsler also has monthly articles here, and a quick comparison suggests that they are different articles than those in Pharmaceutical Technology.

Biotechniques. One Research Drive, Suite 400A, Post Office Box 1070, Westborough MA 01581-6070. Very technical; for instance, one title from the July 2002 edition is "Performance of in-line microfluidic mixers in laminar flow for high-throughput flow cytometry".

Modern Drug Discovery. Published by American Chemical Society, Editorial office: 1155 16th St., NW, Washington D. C. 20036. Discovery and development.

Drug Delivery Technology. Drug Delivery Technology LLV, 350 Main Road, Montville, NJ 07045.

Spectroscopy. Another Advanstar publication. Related to pharmaceutical work because spectroscopy is involved in many pharmaceutical tests and assays.

LC/GC. Also Advanstar, and probably even more relevant to pharmaceutical work than is Spectroscopy.

Bio×IT World. Bio×IT World, Inc., P. O. Box 9010, Framingham MA 01701. (Subscription inquiries: P. O. Box 3414, Northbrook IL 60065) Subheading is "Information Technology for the Life Sciences".

Internet URLs:

I do not believe everything I see on the Internet, but I think that the following sites are reliable, and you may find them useful.

Search the Code of Federal Regulations (CFR). Pharmaceuticals are in Title 21.

www.fda.gov; www.fda.gov/cder/handbook/

www.labcompliance.com Regulatory information

www.usp.org The USP site; you can order USP publications.

www.pharmaportal.com Full text articles from Pharmaceutical Executive, Applied Clinical Trials, Pharmaceutical Technology, BioPharm, Healthcare Media, Spectroscopy, and LC/GC. I have not been able to find the technical supplements from BioPharm at the web site, though.

www.iscpubs.com Articles from 17 publications, including American Laboratory, American Biotechnology Laboratory, etc.

www.biotechniques.com BioTechniques; searchable, but apparently no full text as of July 2002 pubs.acs.org/mdd Modern Drug Discovery magazine.

www.drugdeliverytech.com Articles appear 2 months after publication.

www.sigma-aldrich.com Chemicals and some equipment

www.vankel.com Pharmaceutical testing equipment

www.fishersci.com (www.fisher.co.uk/;

www.fisherww.cz/; www.de.fishersci.com; www.nl.fishersci.com; or search for 'Fisher Scientific'). Laboratory equipment

www.vwr.com; www.vwrsp.com (or search for "VWR")

www.sargentwelch.com Laboratory equipment, general

Internet sites do not replace good printed references, but here are some glossaries that you may find helpful:

The home page does not have an obvious link to the glossary, which is a rather odd combination of bioscience and computer; many acronyms.

English; many acronyms.

English, searchable

A German glossary of terms related to pharmacokinetics, with English equivalents

or allserv.rug.ac.be/~rvdstich/eugloss/language.html
Multilingual glossary of medical terms, searchable in Danish, Dutch, English, French, German, Italian, Portuguese, or Spanish

or medlineplus.adam.com/
Click on "Dictionaries", then "ADAM Medical Encyclopedia" or other entries.

www.vh.org/Providers/ClinRef/FPHandbook/Abbreviations.html Medical acronyms, English

And, for more references: www.accurapid.com/journal/
and the selection "Web Surfing for Fun and Profit" by Cathy Flick.

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