Comparative drug safety data for an evolving pharmacovigilance environment
A systemic approach to pharmacovigilance, taking into account signals from multiple sources of information – including literature and spontaneous adverse event reports – is needed to make the best risk-benefit decisions.
How PharmaPendium helps
PharmaPendium provides comparative regulatory-based evidence in a single database, informing critical pre- and post-market drug safety activities.
It provides searchable FDA and EMA regulatory documents, Adverse Events Reports and FDA Advisory Committee meetings, along with unique FAERs search capabilities and extracted pharmacokinetic, efficacy, safety and metabolising enzyme and transporter data. PharmaPendium helps users:
- 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
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- Predict drug-drug interactions to ensure more effective risk management strategies
- Anticipate potential safety risks in both clinical studies and post-market
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.
How PharmaPendium supports Drug Safety
PharmaPendium provides fully searchable, deeply extracted information from FDA and EMA regulatory documents, unique FAERS search capabilities, and a powerful tool for predicting multiple drug–drug interactions (DDIs) simultaneously.
Download the PharmaPendium Fact Sheet (PDF, 985kb)
Optimize drug candidate selection and mitigate the risk of sub-optimal clinical trial study designs with deeply enriched, comparative efficacy data extracted from FDA and EMA drug approval documents.
Download the Efficacy Module Fact Sheet (PDF, 2.6mb)
Identify and assess potential drug-drug interactions (DDI) with a powerful DDI Risk Calculator along a unique source of extracted, easily searchable pharmacokinetic (PK) and metabolizing enzyme and transporter (MET) data.
Download the DMPK Fact Sheet (PDF, 1.1mb)
Ideas and insights for industry professionals
Making the most of spontaneous reporting data
Detecting signals from spontaneous reporting data is critical as they represent an unrestricted view of the adverse events landscape. However, this data is cluttered by heterogeneity and biases. See how to make the most of the data you need.
Improving the accuracy of signal detection
Pharmacovigilance ensures the correct use of a drug, safeguarding it as a meaningful treatment option. But working with spontaneous adverse event reporting systems poses challenges. Find out how to overcome them.
Learn more about Elsevier's R&D Solutions for Pharmacovigilance
Achieve pharmacovigilance with less pain with solutions that help you identify critical patient safety signals and automate the processes of capturing and managing adverse drug reaction and safety information,
Learn more about Pharmacovigilance solutions