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 metabolising 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
- rapid evaluation of potential drug-drug interaction risks
- increased chances of successful submissions to regulatory authorities
- improved clinical trial designs by optimising 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 to 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, efficacy, safety and metabolising enzyme and transporter 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.
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, optimised study designs that take drug candidate efficacy and efficacy precedents into account are an essential part of risk mitigation.
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.
What our customers say
"Instead of spending weeks gathering data that we’d then have to standardise, we now spend half a day on PharmaPendium." Dr. Kevin Lustig, President & CEO The Assay Depot Inc.Read the case study (in English)
"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
"[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
If you have questions about third-party licensing or how publishers’ content appears in the product, please contact the Publishing Relations Management team.
More information (in English)
- Download the PharmaPendium fact sheet (PDF, 409kb)
- Download the efficacy module fact sheet (PDF, 2.6mb)
- Download the pharmacokinetics fact sheet (PDF, 875kb)
- Download the metabolising enzymes & transporters fact sheet (PDF, 1.2mb)