Who uses PharmaPendium?
What can PharmaPendium do?Successful drug development means making the right decisions at every stage of the process, from preclinical research through clinical trials and regulatory submissions to release and marketing. PharmaPendium is the ideal information management tool to support you in this process thanks to its comprehensive and expertly curated databases and superior interface. It is designed to help you manage and compile information on your drug candidates.
PharmaPendium has the answers to all the questions you need to ask during every stage of your drug development process.
- What support can I get for my preclinical research?
- How can I optimize my drug safety analyses?
- What pharmokinetic and clinical exposure data can I access?
- How can I best make my case for this drug to the regulatory authorities?
- How can PharmaPendium help me to manage information?
Your PharmaPendium story
What support can I get for my preclinical research?
PharmaPendium gives you access to safety, efficacy and DMPK data and comparative preclinical research information that you cannot find anywhere else. These relevant data will enhance your preclinical research and preclinical imaging and help you take the most appropriate actions in preclinical trials and studies from a scientific, business, and regulatory perspective. Better understand risk factors, species specificity and the likelihood of safety issues arising as you go from preclinical trials to clinical trials and beyond. Ultimately, PharmaPendium gives you the information that you need to present the strongest and most complete case to your regulatory authorities.
How can I optimize my drug safety analyses?
PharmaPendium helps you to conduct thorough toxicology research analyses, study adverse drug reactions, and locate important information on concomitant drugs. Thanks to the wealth of data on structural similarities and common pharmacology between drugs, you can identify possible adverse effects and species-specific behavior. Further insight is supplied by extracted safety data from FDA and EMA documents about successful experimental designs and approved drugs.
What pharmokinetic and clinical exposure data can I access?
PharmaPendium contains an optional module that has been specially designed to help you find all the relevant pharmokinetic data on your drug candidate. Our Pharmacokinetics Module gives you direct access to preclinical and clinical exposure data, such as Cmax, Tmax and AUC, extracted from the whole FDA Approval Package and EMA document libraries. For a better overview, all of the pharmacokinetic and preclinical and clinical exposure data are searchable and filterable in one platform.
How can I best make my case for this drug to the regulatory authorities?
PharmaPendium allows you to access all of the available regulatory precedents so that you can present the most compelling case in the increasingly risk-adverse regulatory climate. Avoid common submission mistakes, shape and strengthen your submissions based on precedents in FDA and EMA regulations, and ensure that only your best and most acceptable experiments are submitted for approval. PharmaPendium can also assist you in highlighting data and decisions from similar cases for citation and in speeding up the approval process.
How can PharmaPendium help me to manage information?
Comprehensive searching and high-precision retrieval are easy thanks to the meticulous indexing and structure of the PharmaPendium databases. You can quickly compile safety and drug-related information from all approved sources and get a superior overview of the state of knowledge on drugs and drug candidates similar to yours. Increase your chances of successful NDA submissions and make confident decisions on candidate drugs throughout your development process with PharmaPendium.
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