Elsevier MDL (NYSE:RUK)(NYSE:ENL)(LSE:REL) is pleased to
announce the release of PharmaPendium(TM) (www.pharmapendium.com), an
essential drug safety resource that provides researchers with
unprecedented access to an online collection of best-in-class drug
safety content, including searchable FDA approval packages.
"Drug safety is a pressing issue for the pharmaceutical industry,
governmental regulators and our public health," said Lars Barfod, CEO
of Elsevier MDL. "Our customers tell us that PharmaPendium meets a
clear need for efficient access to drug safety data and can help make
an important difference in drug research."
The concept for this resource was developed with input from
various preclinical researchers utilizing drug safety in their daily
work. Extensive input was also provided by the FDA under a Cooperative
Research and Development Agreement (CRADA) between the FDA and MDL
Information Systems. Dr. Edwin Matthews and Dr. Joseph Contrera, FDA's
Center for Drug Evaluation and Research, Office of Pharmaceutical
Science, are the FDA Investigators on the CRADA. "We believe this
concept will be very useful to the scientific community and to our own
research on the adverse effects and toxicological activities of
pharmaceuticals. This resource could also be an important tool to
facilitate the goals of the FDA's Critical Path Initiative
(http://www.fda.gov/oc/initiatives/criticalpath/), and to support drug
safety and drug development programs."
PharmaPendium is the only product featuring searchable access to
FDA Approval Packages. Researchers and information specialists no
longer have to order relevant packages and spend weeks or months
sifting through long documents looking for pertinent information.
PharmaPendium provides a longitudinal view of preclinical, clinical
and post-market safety data, which allows researchers to determine
what observed effects in animals translate to humans for similar
candidate compound drugs. In addition, the resource provides four
pathways into drug safety information: by drug (class), by adverse
effect/toxicity, by target and by chemical structure.
PharmaPendium will help toxicologists, safety pharmacologists,
drug safety team members and information specialists in the
pharmaceutical sciences. Other key resources such as the Adverse Event
Reporting System (AERS), Meyler's Side Effects of Drugs and Drug
monographs from Mosby's Drug Consult(TM) can be searched in seconds,
saving hours for preclinical and clinical researchers. In addition,
selected terminology from the Medical Dictionary for Regulatory
Activities (MedDRA(R)) has been built into PharmaPendium to enhance
intelligent searching and browsing of side effect content. As a
knowledge database leader, Elsevier MDL is committed to providing
pharmaceutical researchers with unprecedented access to essential drug
safety information.
About Elsevier MDL
Elsevier MDL provides informatics, database and workflow solutions
that accelerate successful life sciences R&D by improving the speed
and quality of scientists' decision making. Researchers around the
world depend on Elsevier MDL for innovative and reliable discovery
informatics software solutions and services augmented by 400 Elsevier
chemistry and life sciences journals and related products. For more
information, visit www.mdl.com. Elsevier is a world-leading publisher
of scientific, technical and medical information products and
services. For more information visit www.elsevier.com.
Elsevier is part of Reed Elsevier Group plc, a world-leading
publisher and information provider. Reed Elsevier's ticker symbols are
REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL
(New York Stock Exchange).
Notes to Editors:
To learn more about PharmaPendium, contact your Elsevier MDL
Account Manager, visit www.mdl.com or www.pharmapendium.com or send a
message to pharmapendium@elsevier.com. Dr. Edwin Matthews
(edwin.matthews@fda.hhs.gov) and Dr. Joseph Contrera
(joseph.contrera@fda.hhs.gov) are the FDA Investigators on the CRADA.
MDL and PharmaPendium are registered trademarks of MDL Information
Systems, Inc. ('Elsevier MDL') in the United States. MedDRA is a
registered trademark of the International Federation of Pharmaceutical
Manufacturers Associations in the United States. Separate license to
MedDRA required. Other names or products may be the trademarks or
registered trademarks of their respective owners. All rights reserved.
