FAQs

PharmaPendium’s searchable FDA/EMA drug approval documents and the extracted data from these reference sources provide essential information to support critical drug safety, drug candidate selection and risk mitigation decisions. Users can leverage precedent information and data: to verify and support experimental findings for safety testing of drug candidates and their selection; to develop preclinical and clinical study designs; and to anticipate potential clinical risks.

PharmaPendium’s comprehensive content updates constantly and includes 75+ years of FDA drug approval packages and 20+ years of EMA approval documents, FDA Adverse Events Reporting System (AERS) reports and additional high-value regulatory-related information and data. In addition, the extracted databases from the FDA and EMA drug approval documents provides a unique translational view across preclinical, clinical and post market to provide deep insights into drug development issues such as drugdrug interactions, therapeutic window and drug safety and adverse events.

Investigators that complete preclinical and clinical drug development research are the main users of PharmaPendium. In particular, scientists who work with DMPK, pharmacodynamics, safety pharmacology, clinical pharmacology, translational and clinical research, and modeling and simulation groups often benefit the most from PharmaPendium’s content.

No, PharmaPendium is a web-based product.

Currently, PharmaPendium is updated about every 2 weeks, which allows end users to incorporate new information into their decisions frameworks rapidly.

PharmaPendium features robust multichannel support. When using the product, users can access training material and user guides through the ‘Help’ function. In addition, our Customer Care team is ready to assist you with any questions you may have.

To find out about pricing, please Contact Sales.

To receive a product demonstration, please Contact Sales.

Technical Product Info

System Requirements for PharmaPendium access

Web Browsers:

  • Mozilla Firefox (the latest 3 versions)
  • Apple Safari (the latest 3 versions)
  • Google Chrome (the latest 3 versions)
  • Internet Explorer 8 or higher

Operating System:

  • Windows Server 2008 R2 SP1 or higher
  • Windows 7, 8, and 8.1
  • Macintosh OS X Mountain Lion (version 10.8)

PharmaPendium PDF Viewer:

Because the latest version of Adobe, Adobe X, no longer supports highlighting from external servers, PharmaPendium now has its own in-house PDF Viewer.  Improvements include:

  • Significantly improved performance when downloading PDFs.  Users should see a performance improvement from 10X to 100X.
  • No software download is needed.  The PDF Viewer is embedded within the PharmaPendium platform.
  • PharmaPendium users can still view and save documents in Adobe if they wish.

Display: Optimized for 1024 x 768 screen resolution.

Support Log In

Existing Customer? Log into the PharmaPendium product site and click on (?) at the top of the page.

Insights

Case Study: Regulatory Pathways

Regulatory Affairs professionals rely on PharmaPendium's robust, high quality information that supports drug approval processes and decisions with instant access to current and archived approvals, drug reviews, preclinical and clinical comparative data and regulatory context.

Regulatory Pathways (PDF, 775kb)

Article: Dealing with Massive Information Flow

A Head of Safety Pharmacology at a market-leading pharmaceutical company discusses the use of PharmaPendium to improve the selection of potential compounds with additional meaningful criteria.

Dealing with Massive Information Flow (PDF, 625kb)

Case Study: Streamlining Drug Development

Collating and analyzing data takes up a significant amount of a drug discovery researcher’s time. Learn how new tools exist to mine and analyze pharma information, empowering researchers during every step of drug development.

Streamlining Drug Dev (PDF, 665kb)

Case Study: Streamlining Workflows

Read how a single PharmaPendium session could save two to three weeks of work.

Streamlining Workflows (PDF, 635kb)

Case Study: Understanding Key Determinants of Drug Activity

This article highlights the increasing role that drug metabolism and transport proteins have in the drug approval process.

Understanding Key Determinants (PDF, 810kb)

Case Study: Model of Intelligence

Read how the high quality data found in PharmaPendium is used in modeling dose exposure and mechanism of drug action.

Model of Intelligence (PDF, 783kb)

Case Study: Making Better, More Informed Decisions

Read how comparative extracted data from FDA/EMA drug approval documents provides valuable insights into drug development programs and decisions.

Making Better Decisions (PDF, 623kb)

More Insights

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