PharmaPendium’s DMPK Solution

Preclinical and clinical risk–benefit analyses are essential for proper prioritization of the drug candidates with the best chance of success. PharmaPendium’s DMPK Solution supports these critical decisions by helping to create a more detailed picture of potential drug–drug interactions (DDIs).

The DMPK Solution delivers the information to answer critical questions such as:

  • What is the risk of adverse interactions with existing drugs?
  • Is the new drug a substrate of an enzyme modulated by other drugs?
  • Can transporters affect the disposition of the new drug?
  • Might the new drug affect the metabolism of other drugs?
  • Have regulatory agencies expressed concerns about potential DDIs?
  • What studies were conducted to assess DDI risks?
  • How do potential interactions affect pharmacokinetic properties?
  • How does the drug candidate compare with drugs that share class, chemistry and target similarities?

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How does the DMPK Solution work?

The DMPK Solution facilitates informed risk assessments with:

  • Extracted pharmacokinetics and metabolizing enzyme & transporter data
  • Comprehensive FDA and EMA approval packages, FDA ACM documents, and literature
  • The new DDI Risk Calculator, which provides a full risk profile against marketed drugs

Unique Content to Enable Thorough Risk Assessment

PharmaPendium’s DMPK Solution is the only tool to provide manually extracted data not only from the relevant literature, but also from FDA and EMA approval packages and FDA Advisory Committee documents. It is the most comprehensive solution for assessing DDI risk across marketed drugs.

The content in the DMPK Solution is:

org box FDA

org box EMA

org box advisory committee meetings

org box drugs indexed and fully searchable

org box extracted PK data lines

org box metabolizing enzyme and transporter lines

org box unique drugs assessed as a victim

org box drugs assessed as a perpetrator

Unique Support for Calculating DDI Risk

The Drug–Drug Interaction Risk Calculator (DDIRC) helps to establish the risks of adverse interactions between drugs in a manner compliant with the 2012 FDA Guidance for Industry Drug Interaction Studies. By helping to identify potential interactions for multiple drugs simultaneously, it provides a full risk profile against marketed drugs (Figures 1 and 2).

This information helps researchers to:

  • Identifying promising candidates with favorable safety profiles
  • Prioritizing DDI clinical studies
  • Determining what drugs can be used concurrently with a drug candidate
  • Establishing initial inclusion/exclusion criteria relating to concomitant drugs
The DDI Risk Calculator - PharmaPendium | Elsevier
Figure 1 The DDI Risk Calculator enables risk assessment of multiple drugs simultaneously. The orange box highlights the highest risk drugs.
Visualization of DDI risk - PharmaPendium | Elsevier
Figure 2 Visualization of DDI risk for drugs at varying doses quickly facilitates decision-making on co-treatment options.

Is the DMPK Solution right for me?

PharmaPendium’s DMPK Solution is designed to provide pharmaceutical developers superior support for more rapid development of safe and effective drugs. It helps DMPK scientists to make informed decisions in drug candidate assessment and clinical trial planning.

Customers who use the DMPK Solution can:

  • Inform decisions on which DDI-focused clinical trials are needed
  • Evidence which DDI-focused trials can be omitted to save time and effort
  • Reveal the risk of interactions with drugs that trial participants already take
  • Identify alternative drugs that would be safer to use as co-medications
  • Evaluate the risk of interactions with common drugs, such as analgesics and anti-histamines

How do I get it?

The DMPK Solution is available as an add-on to a PharmaPendium subscription.

If you are interested in learning more about how the DMPK Solution can help your organization, submit a request to have an Elsevier representative contact you.