Elsevier, the information analytics company specializing in science and health, has launched the PharmaPendium DMPK (Drug Metabolism-Pharmacokinetic) solution. The DMPK solution delivers searchable pharmacokinetic, metabolizing enzymes and transporters data to provide a complete picture of potential drug-drug interactions (DDIs) and drug candidate risk assessment.
PharmaPendium DMPK informs preclinical and clinical risk/benefit analyses – enabling researchers to make quick evaluations of which drug candidates to progress. The DMPK solution also includes a drug-drug interaction risk calculator (DDIRC), which is compliant with 2012 FDA guidelines on Industry Drug Interaction Studies. Together, the solutions support informed and accelerated decision-making.
In drug discovery and development, early and ongoing assessment of DDIs is critical. Undetected DDIs can lead to severe side effects, resulting in the refusal of regulatory approval, severe prescribing restrictions or the withdrawal of drugs from the market. The FDA reports that between 1995 and 2010, the proportion of adults dispensed five or more drugs doubled to 20.8%; the proportion dispensed ten or more tripled to 5.8%. DDIs account for between 3-5% of all reported adverse drug events and, with an aging population and this increasing trend towards polypharmacy, are an urgent concern.
PharmaPendium’s DMPK Solution provides a unique source of searchable pharmacokinetic, metabolizing enzyme and transporter data and, together with DDIRC, allows users to predict potential interactions between an investigational drug and multiple drugs simultaneously – providing a full risk profile against marketed drugs.
“PharmaPendium’s DMPK and DDIRC tools have had a significant impact on our drug development decisions,” commented a senior DMPK scientist from a top pharma company that beta-tested the solution. “The solution delivers a level of information we can’t get elsewhere, so we can get a full, detailed picture of risk assessment classified by therapeutic class. Without the DDI risk calculator, we would only focus on key drugs. But with DDIRC, within 30 minutes to half a day, we can analyze over 200 drugs – so it really saves us considerable time.”
“For all scientists and researchers, patient safety is the paramount concern. Currently, identifying and assessing potential DDIs is an essential but resource-intensive task,” said Guenther Kurapkat, Senior Vice President of Life Science Solutions, Elsevier. “The DMPK solution and DDI risk calculator save both time and cost. Not only by allowing comprehensive and simultaneous analyses of drug candidates, but also delivering more relevant information to the hands of scientists. This allows them to quickly and confidently prioritize the safest, most promising candidates for further development – and also supports more intelligent, and safer clinical trial design.”
The DMPK solution contains over 2.2M pages of FDA approval documents, 680K pages of FDA Advisory Committee documents, and 200K pages of EMA approval documents. Over 4,400 drugs are indexed and fully searchable; with 1.6M extracted pharmacokinetic data lines and over 302K metabolizing enzyme and transporter lines. It delivers the information that scientists need to answer critical questions during drug development; including what other studies were conducted to assess DDI risks and what concerns regulatory agencies have previously expressed about potential DDIs.
The PharmaPendium DMPK Solution and DDIRC are available from June 19, 2017. For more information, please visit https://www.elsevier.com/solutions/pharmapendium.
