PMRs/PMCs for drugs approved by the FDA in 2014, 2015, and 2016 – Additional information now available in DIDB

As the DIDB content continues to expand, we are pleased to announce that post-marketing requirements and post-marketing commitments (PMRs and PMCs) for drugs approved by the FDA in 2014, 2015, and 2016 have now been entered in the DIDB. The DDI, hepatic impairment, and renal impairment results can be found under the drug’s original NDA or BLA numbers. Updated label recommendations are also presented in the drug DDI Summary.

Having access to this additional information is key to fully understand the DDI profile of NMEs, and the DIDB Editorial Team is now working on PMR/PMC data for drugs approved in 2017 and 2018.

As always, feel free to contact us at DIDBase@certara.com if you have any questions or comments.

Video tutorials for DIDB users – Updated

Did you know that we have recently recorded / updated 19 training videos to help DIDB users to make full use of the database?

Those videos are available in the DIDB Resource Center as well as on the DIDB pages that are relevant to their content. For example, on the Drug Query page you have access to 3 related videos, on the QT Interval page to 1 related video …

Please note that you must be signed-in to access.

Feel free to suggest additional topics for training videos that you will find useful. Please contact us. Thank you.

Video Tutorials – Increased Visibility

Did you know that we have recorded 10 training videos so far, which are all available in the DIDB Resource Center?

In order to best benefit the DIDB users, the videos are now also accessible on the DIDB pages that are relevant to their content. For example, on the Drug Query page you have access to 3 related videos, on the QT Interval page to 1 related video …

Please note that you must be signed-in to access.

Feel free to suggest additional topics for training videos that you will find useful. Please contact us. Thank you.

New features! Drug Characteristics queries expanded, and Invite a colleague to use DIDB

Drug characteristics queries are expanded from AUC-CL change queries to Drug queries. Two drug queries are now enabling users to search using object or precipitant characteristics

  • the Drug queries with Objects
  • the Drug queries with Precipitants

Invite a colleague to register to access DIDB. With this feature most of you (some restrictions apply based on the license type) can now invite a colleague from your company to register to access DIDB. Anyone working in preclinical DMPK, Clinical Pharmacology, Safety, Medical, and Regulatory Affairs can benefit from using DIDB.

When you are signed in DIDB, you can use the “invite a colleague” green button located on the right side of each of the DIDB pages, alongside the “contact us” blue button.

As always, feel free to contact us if you have any questions or comments. Your feedback is critical to make the most of the DIDB content and functionalities!

New features! Drug Characteristics now integrated in queries

DIDB Drug Characteristics include several key drug properties such as:

  • substrate sensitivity, 
  • precipitant potency, 
  • QT prolongation, 
  • narrow therapeutic index. 

These characteristics are now embedded in most query results and are presented for both the object and the precipitant drugs, if applicable. 

The addition of drug characteristics to the table of results provides contextual information enabling a better understanding of the drug-drug interaction data and its clinical relevance.

As the next step, drug characteristics will power DIDB searches. To start, two in vivo queries are now enabling users to search using object or precipitant characteristics

  • the “Percent Change in AUC or CL” queries with Objects, 
  • the “Percent Change in AUC or CL” queries with Precipitants,

Please contact us if you find this new feature useful before we expand it to additional queries. As always, your feedback is critical to make the most of the DIDB content and functionalities!

New features! AUC and Cmax (90% CI) data, PGx-FDA label, and more

DIDB has been updated with the following new features:

  • AUC and Cmax GMRs (90% CI) are now systematically presented in the study results view (when available) and are used to calculate changes in exposure data
  • Links to PGx external resources have been added to pharmacogenetics queries to provide users with additional contextual information
  • New drug characteristic “PGx (FDA label)” highlights drugs with PGx-related recommendations in FDA label
  • Continuous expansion of compound PK parameters

Feel free to contact us if you experience any issues or if you have any questions or suggestions. Your feedback is always greatly valued!

New Name and Additional Data! for the CYP/P-gp Substrates and Perpetrators Lists

Our new “DDI Marker Studies Knowledgebase” (in Excel) is now available in the Resource Center and replaces the previous combined and individual lists of CYP/P-gp substrates and perpetrators.

The Knowledgebase represents a comprehensive list of compounds that are sensitive or moderate sensitive substrates (NEW), inhibitors, or inducers of CYP enzymes (weak-to-strong potency assigned) and the P-gp transporter.

You can generate an individual list of a specific CYP isoform or transporter as shown in the video (at the bottom of the page).

Additionally, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g., dose proportionality, accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics.

The Knowledgebase will be updated quarterly.

Feel free to contact us if you experience any issues or if you have any questions or suggestions. Your feedback is always greatly valued!

New features! and improvement of existing queries

DIDB has been updated with the following new features:

  • Citations recently published” and “NDA/BLAs recently enters” can retrieve citations and NDA/BLAs containing PGx data only
  • The above result pages show if the citation or NDA/BLA contains in vitroin vivo, or PGx content
  • All the “In Vitro Parameter Queries” take multiple compounds
  • All query results now 
    • use the therapeutic class format of presenting two levels, e.g., “Antiemetics ⟶ Neurokinin-1 Receptor Antagonist”
    • both levels of the therapeutic class are links directed to the therapeutic class DDI risk assessment
    • drug names are now links if there is any DDI summary/QT summary/PK profile in their monographs

Feel free to contact us if you experience any issues or if you have any questions or suggestions. Your feedback is always greatly valued!

Watch our collection of short video tutorials

We have initiated a [How to]… Series of 2-min videos, to show how to search, explore, use, some specific content in DIDB. So far, we have recorded videos on combination drugs, racemate and enantiomers, QT interval prolongation, and drug monographs.

If you have in mind any information you find difficult to retrieve in DIDB, feel free to contact us. We will get back to you and can decide to explain it in a short video.

The videos are available in DIDB Resource Center. Please note that you must be signed in to access.