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NEW YORK, October 14 /PRNewswire-FirstCall/ --
- Site Becomes the Only Source of Consolidated, Searchable Access to Both FDA and EMEA Drug Approval Documents
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
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