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Elsevier MDL Unveils Pharmapendium a new Drug Safety Product

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lsevier MDL has announced the release of PharmaPendium™, a 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, 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™ can be searched in seconds, saving hours for preclinical and clinical researchers.

In addition, selected terminology from the Medical Dictionary for Regulatory Activities (MedDRA®) 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.