Elsevier's PharmaPendium(TM) Adds European Medi...
NEW YORK, October 14 /PRNewswire/ --
- Site Becomes the Only Source of Consolidated, Searchable Access to Both
FDA and EMEA Drug Approval Documents
NEW YORK, October 14 /PRNewswire/ --
PharmaPendium ( http://www.info.pharmapendium.com/ ),
Elsevier's online resource for authoritative drug safety data, has
significantly expanded its content offering with a new release containing the
European Medicines Agency's (EMEA) European Public Assessment Reports
(EPARs). The addition of this content makes PharmaPendium the only source of
consolidated, searchable access to US Food and Drug Administration (FDA) and
EMEA drug approval documents on a single site, with a single search.
EMEA is the European agency for the evaluation of medicinal
products. This new content offers critical insights into the EMEA regulatory
point of view, their reasoning underlying drug approval and the
qualifications put on that approval.
"The Pharmaceutical industry is facing increasing pressure to
identify drug candidates with the best possible safety, delivery and efficacy
profiles as early as possible and PharmaPendium is uniquely positioned to
address these challenges," commented Philip MacLaughlin, Senior Product
Manager at Elsevier.
The EMEA's EPAR documents cover medicines assessed by the
Committee for Medicinal Products for Human Use (CHMP). EPAR documents include
efficacy, indication, safety and pharmacokinetics data and mode of action
information. The EMEA database on PharmaPendium makes readily accessible
approximately 80,000 pages of searchable documents for more than 300 active
ingredients approved for the European market - some not approved in the US.
It also presents preclinical and clinical toxicity and adverse effects data
manually extracted from these documents. General product information
documents are also included.
"Providing our users with the European Medicines Agency
documents adds another important dimension to our coverage," said
MacLaughlin. "This information will benefit companies operating globally
because it provides critical access to another major regulatory body's points
of view, precedents and data, including drugs approved only in Europe, and
the availability of this information, combined with the FDA documents and
other PharmaPendium data sources, will lead to a deeper understanding of the
full scope of projected risks early in the drug development process and
consequently reduce drug development costs and avoid regulatory cycling."
The EMEA Documents database is included as part of
PharmaPendium licensing agreements at no additional fee and the content is
automatically available to all users. More information about the European
Medicines Agency and EMEA approval documents can be found at
http://www.info.pharmapendium.com/emea.
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 B.V.
Contact:
Tom Reller,
Director of Corporate Relations,
Phone: +1-212-462-1912,
E-mail: T.Reller@Elsevier.com .
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