Elsevier's PharmaPendium(TM) Introduces the FDA...

NEW YORK, June 2 /PRNewswire/ --

- Includes All FDA Drug Approval FOI Documents Through 1991

NEW YORK, June 2 /PRNewswire/ --

    PharmaPendium (http://www.info.pharmapendium.com/), Elsevier's online
resource for authoritative preclinical, clinical and post-marketing drug
information, has significantly expanded its coverage of US Food and Drug
Administration (FDA) approval documents with the launch of the FDA Classic
Collection. This collection contains all available historical FDA approval
documents up to and including those issued in 1991 - all indexed and made
searchable for the first time in history. With the addition of the FDA
Classic Collection, PharmaPendium has become the only integrated, searchable
source of all FDA drug approval documents.



    The combination of PharmaPendium's current FDA database and the FDA
Classic Collection creates an entire searchable library of documents written
by the FDA on the approval of drugs and their pharmacokinetics, efficacy and
safety. The FDA Classic Collection may be searched simultaneously with the
current file (1992-present) or as a discrete database.



    "For success within the pharmaceutical industry it's critical to gain and
maintain a strong competitive advantage and avoid lost opportunities, lost
sales, wasted trials and regulatory recycling. The addition of the FDA
Classic Collection to PharmaPendium gives pharmaceutical companies the
advantage of being able to gain a unique perspective into the past, enabling
them to benefit from information that has not been available for close to 50
years. Users will be able to apply modern analyses tools to these data for
the first time, generating new insights. They will no longer encounter
information dead ends because every citation to a previous FDA document is
now traceable, searchable and viewable," commented Philip MacLaughlin, Senior
Product Manager at Elsevier.



    Most of the documents in PharmaPendium's FDA Classic Collection were
previously available only through direct requests to the FDA/Center for Drug
Evaluation and Research Freedom of Information Office and had to be pulled
from microfiche. "Now users can locate and search these historic documents in
just seconds to uncover regulatory precedents, learn from historic mistakes
and successes and apply these lessons to current projects in the drug
pipeline," continued MacLaughlin.



    The FDA Classic Collection may be added to new or existing PharmaPendium
licenses for an additional fee.



About PharmaPendium(TM)

    PharmaPendium (http://www.info.pharmapendium.com/), The Essential 
Resource for Preclinical Safety and Risk Assessment, is a unique online 
resource that provides access via a single point to searchable and trusted 
drug information. It covers over 3100 approved drugs, with integrated 
preclinical, clinical and post-marketing safety data.



    PharmaPendium is designed to meet the needs of preclinical safety
assessment teams, toxicologists, pharmacokineticists, safety pharmacologists,
regulatory affairs staff, pharmacoepidemiologists, clinical researchers and
information specialists. It enables text-search of FDA Approval Packages and
European Medicines Agency (EMEA) European Public Assessment Reports (EPAR)
Approval Documents as well as other data sources. Adverse events and toxicity
data are carefully extracted from preclinical and clinical studies from all
of these sources. Elsevier offers a broad spectrum of solutions to make
processes in drug discovery, preclinical and clinical drug development more
efficient, e.g. CrossFire and Reaxys, EMBASE and PharmaPendium. More
information can be found at http://www.elsevierforindustry.com.



About Elsevier

    Elsevier is a world-leading publisher of scientific, technical and 
medical information products and services. Working in partnership with the 
global science and health communities, Elsevier's 7,000 employees in over 70 
offices worldwide publish more than 2,000 journals and 1,900 new books per 
year, in addition to offering a suite of innovative electronic products, such 
as ScienceDirect (http://www.sciencedirect.com/), MD Consult (
http://www.mdconsult.com), Scopus (http://www.info.scopus.com/),
bibliographic databases and online reference works.



    Elsevier (http://www.elsevier.com/) is a global business headquartered in
Amsterdam, The Netherlands and has offices worldwide. Elsevier is part of
Reed Elsevier Group plc (http://www.reedelsevier.com/), a world-leading
publisher and information provider. Operating in the science and medical,
legal, education and business-to-business sectors, Reed Elsevier provides
high-quality and flexible information solutions to users, with increasing
emphasis on the Internet as a means of delivery. Reed Elsevier's ticker
symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and
ENL (New York Stock Exchange).



PharmaPendium is a trademark of Elsevier Inc.

    
    Media Contact:

    Tom Reller
    Elsevier
    [phone]
    [e-mail]