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.
With searchable FDA/EMA drug approval documents and comparative drug safety, pharmacokinetic, efficacy and metabolizing enzyme and transporter data, PharmaPendium helps you with:
- Better risk assessments of your drug candidate’s toxicity
- Detailed assessments of your drug candidate’s PK parameters and properties
- Better assessment of the best animal model to use and how results will translate to the clinic
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- Rapid evaluation of potential drug-drug interaction risks
- Increased chances of successful submissions to regulatory authorities
- Improved clinical trial designs by optimizing selection of sample size, primary/secondary endpoint and study design
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. Fully searchable FDA and EMA regulatory documents, Adverse Events Reports and FDA Advisory Committee meetings, along with unique FAERs search capabilities and extracted pharmacokinetic (PDF, 854kb), efficacy (PDF, 2.6mb), safety and metabolizing enzyme and transporter (PDF, 1.2mb) data allow you 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
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.
Learn how to quickly assess DDI risk
Translational & 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.
Learn more about translational & clinical research
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.
Learn more about interoperability with Embase
What our customers say
"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.
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.
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.
PharmaPendium fact sheets
PharmaPendium offers dedicated data modules that provide insights and information on the critical focused areas of drug development, drug safety, ADME and drug-drug interactions.
Download the PharmaPendium Fact Sheet (PDF, 409kb)
If you have questions about third party licensing or how publishers’ content appears in the product, please contact the Publishing Relations Management team.
Gain key insights on drug efficacy benchmarks from approved drugs:
In drug development, it is essential to 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 new Efficacy Module for PharmaPendium delivers those insights, enabling more informed decisions in translational and clinical study design.
Download the efficacy module fact Sheet (PDF, 2.6mb)
Access preclinical and clinical exposure data:
Refine therapeutic window analyses and experimental design with high quality precedent data from approved drugs.
Download the Pharmacokinetics fact sheet (PDF, 875kb)
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)
Identify and assess drug-drug interactions:
Evaluate potential drug-drug interactions, drug efficacy and toxicity with a comprehensive database of pharmacokinetic and metabolizing enzyme and transporter information, along with a powerful DDI Risk Calculator.
Download the DMPK fact sheet (PDF, 1.1mb)