High-recall, high-precision capture of adverse drug reactions
Making the best drug risk–benefit decisions requires comprehensive information. A systemic approach to pharmacovigilance considers signals from multiple sources of information – including peer-reviewed literature, spontaneous adverse event reports and other regulatory documents.
How PharmaPendium helps
Designed to support critical decisions in pre- and post-market drug safety workflows, PharmaPendium provides comparative regulatory-based evidence in a single database. It offers:
- Comprehensive access to searchable regulatory documents from the FDA and EMA
- Dedicated search functions for the FDA Adverse Event Reporting System (FAERS), including tools to reveal differences in adverse event reporting
- Extracted comparative data on safety, pharmacokinetics, efficacy, and metabolizing enzymes and transporters.
PharmaPendium ensures that users can:
- Find post-market safety data to augment PV reporting requirements
- Identify safety signals and drug–drug interaction risks in a timely manner
- Reveal potential DDI risk in with pairs of concomitant drugs and substances
- Build more effective evidence-based risk management strategies
- Anticipate potential safety risks in clinical studies and post-market
- Perform all searches in alignment with ICH’s MedDRA terminology
Early predictions about potential DDIs
Predicting potential adverse interactions between candidate compounds and marketed drugs is critical in ensuring safety in clinical trials and beyond. PharmaPendium’s new DMPK Solution leverages excerpted PK and ME&T data, FDA and EMA documents, and literature along with a powerful DDI Risk Calculator to reveal drug safety early in development.
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
How PharmaPendium supports drug safety
PharmaPendium offers dedicated functionality and data modules that provide insight into drug safety, including drug–drug interactions and spontaneously reported adverse events from the FDA Adverse Event Reporting System.
Download the PharmaPendium fact sheet (PDF, 0.604 MB)
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 fact sheet (PDF, 2.3 MB)
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, 0.693 MB)
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.
Read the white paper
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.
See the white paper
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