PharmaPendium ®

Fully searchable drug approval documents and extracted data to inform critical drug development decisions.

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Better signal detection

Detecting data signals from spontaneous reporting can be challenging because the landscape can be very cluttered by data heterogeneity and biases. See how to overcome it.

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The key to avoiding DDIs

Today, drug-drug interactions (DDIs) account for 3-5% of all reported adverse drug reactions. Find out how to best identify potential DDIs and assess their risk.

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Look ahead to determine the best drug development strategy


Challenges are inevitable on the path to regulatory approval of drug candidates. Successful drug development involves anticipating those challenges as early as possible.

Comparative and up-to-date clinical information is needed to verify pharmacokinetic and experimental data, anticipate species-specific issues in translating in vitro and in vivo studies, predict potential drug–drug interactions and design clinical trial studies to best preclude regulatory issues.

Providing comprehensive access to searchable regulatory documents from the FDA and EMA, dedicated search functions for the U.S. FDA Adverse Event Reporting System (FAERS), and comparative safety, pharmacokinetic, efficacy, and metabolizing enzyme and transporter data, PharmaPendium is an essential resource to support essential decisions in drug development. It helps users with:

Look ahead to determine the best drug development strategy - PharmaPendium | Elsevier Solutions

  • Better risk assessments of drug candidate toxicity
  • Rapid evaluation of drug–drug interaction risks
  • Detailed information on drug candidate PK parameters
  • Easy access to drug candidate efficacy data

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  • Better assessment of animal model applicability
  • Translational insights for clinical success prediction
  • Improved clinical trial designs
  • Increased chances of successful regulatory submissions

Regulatory knowledge at your fingertips

Access to comprehensive drug safety information, drug metabolism, clinical efficacy data and drug approval documents helps researchers answer critical preclinical questions and increases confidence in drug development decisions. PharmaPendium provides comparative regulatory-based evidence in a single database, informing critical pre- and post-market drug safety activities. Users gain access to searchable FDA and EMA regulatory documents, including reports from the FDA Advisory Committee and FAERS (PDF, 985kb), and to extracted pharmacokinetic (PDF, 854kb), efficacy (PDF, 2.6mb), safety and metabolizing enzyme and transporter (PDF, 1.2mb) data. This empowers workflows that require users to:

  • Find and export post-market safety data to augment PV reporting requirements
  • Identify safety signals and drug-drug interaction concerns that become evident post-market
  • Predict drug–drug interactions to ensure more effective risk management strategies
  • Anticipate potential safety risks in both clinical studies and post-market

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Comprehensive assessment of DDI risk

Drug–drug interactions (DDIs) can lead to severe side effects and have resulted in refusal of approval, prescribing restrictions, withdrawal from the market and, in extreme cases, deaths. Identifying and assessing the risk of DDIs is a priority during drug development to ensure patient safety as well as a comprehensive risk management strategy.

Quickly assess DDI risk

Translational and clinical research

Phase II efficacy-related clinical trial failure rates can be as high as 57%, driving pharmaceutical companies on a quest to improve outcomes. As clinical trials become more complex and costly, optimized study designs that take drug candidate efficacy and efficacy precedents into account are an essential part of risk mitigation.

Gain translational insights

Interoperability with Embase

PharmaPendium and Embase work together to provide streamlined and comprehensive information that better informs your risk management strategy. Searching for a drug in PharmaPendium triggers a matched search in Embase and linked access to relevant information from the biomedical literature.

Discover the Embase connection

Easy searching of FAERS

The FDA Adverse Event Reporting System (FAERS) is a valuable source of real-world evidence about post-market drug safety. The PharmaPendium FAERS Data functionality enables specific searching of FAERS to not only find reports, but also compare and visualize adverse events reported for a drug or group of drugs, helping users more easily identify co-morbidities or potential DDIs not evident during clinical trials.

Delve into FAERS

What our customers say

Reducing adverse event risk with informed, data-driven decisions about DDIs - PharmaPendium | Elsevier

The key to avoiding DDIs

Today, drug-drug interactions (DDIs) account for 3-5% of all reported adverse drug reactions. Find out how to best identify potential DDIs and assess their risk.

Read the customer story

"You can have better risk mitigation strategies if you can depend on the information that you've found. The more information you have, the more informed choices you can make.... PharmaPendium helps us to make better, more informed decisions." Specialist, major pharmaceutical company

Read the customer's story (PDF, 622kb)

"[PharmaPendium] is very useful, particularly when dealing with regulatory submission packages for FDA and the EMA, to see the information on which their decisions were made." Laura Newman, Scientist


Read this customer's story (PDF, 783kb)

Drug safety webinar


Learn how PharmaPendium allows you to leverage regulatory context and extracted drug safety, PK and metabolizing data to help address drug safety assessment questions that often arise during clinical development.

Watch the webinar

The Hive: Real Stories. Real Science. Real Time.

Biotech and pharma start-ups are using Elsevier's R&D solutions to solve for early-stage drug discovery and development. To find out more, watch the videos, read real-world case studies and learn how early innovation starts with early access to research.

Visit The Hive

Pharma R&D Today blog


Get a wide range of the latest insights and opinions on pharma-related topics with the Elsevier Pharma R&D blog.

Learn about target identification, big data, new drug discovery, drug safety monitoring, risk mitigation, regulatory compliance and much more.

Visit our pharma blog

PharmaPendium fact sheets

PharmaPendium offers dedicated data modules and search functionalities that provide insights and information to support investigations of drug development, drug safety, ADME and drug–drug interaction.
Download the PharmaPendium Fact Sheet (PDF, 883kb)

Drug safety

PharmaPendium has dedicated functionality and data modules that provide insight into drug safety, including drug–drug interactions and spontaneously reported adverse events, together with a powerful Drug–Drug Interaction Risk Calculator.
Download the drug safety fact sheet (PDF, 985kb)

Efficacy

Gain insight into drug efficacy to help with triaging drug candidates, designing better studies for clinical trials, and selecting the most appropriate clinical endpoints and indications. The Efficacy Module enables more informed decisions in translational and clinical study design.
Download the efficacy fact sheet (PDF, 2.6mb)

Pharmacokinetics

Access preclinical and clinical exposure data to help understand drug pharmacokinetics. Refine therapeutic window analyses and experimental design with high quality precedent data from approved drugs.
Download the pharmacokinetics fact sheet (PDF, 854kb)

Metabolizing enzymes and transporters

Model drug behavior in vivo. Explore this vast database to anticipate drug–drug interactions, drug efficacy and toxicity.
Download the metabolizing enzymes & transporters fact sheet (PDF, 1.2mb)

DMPK

Identify and assess drug–drug interactions (DDIs), drug efficacy and toxicity with a comprehensive database of pharmacokinetic and metabolizing enzyme and transporter information, and gain deeper insights into risks with the powerful DDI Risk Calculator.
Download the DMPK fact sheet (PDF, 1.1mb)

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