Category: News

The draft guidance newly released by FDA on “Clinical Drug Interaction Studies Combined with Oral Contraceptives” is now available in DIDB Resource Center. Please note that you must be signed in to access.

This draft guidance focuses on evaluating the DDI potential of an investigational new drug (i.e., perpetrator) on combined oral contraceptives  (COCs; i.e., victim) during drug development and determining how to communicate DDI study results and mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling.

In DIDB (as of Nov 2020), there are over 600 entries evaluating COCs as an object in dedicated clinical PK studies (including PGx data). On the other hand, nearly 200 entries were curated from clinical DDI studies where COCs serve as a precipitant.

The guidance newly released by FDA on “Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling” is now available in DIDB Resource Center. Please note that you must be signed in to access.

For your information, DIDB contains study results from organ impairment studies following the recommendations in the FDA guidances on impaired renal function and on impaired hepatic function. As such study design, population, degree of organ impairment, drug dosing, PK, PD, and safety results are extracted from the literature and NDAs/BLAs reviews and entered in DIDB.

The draft guidance newly released by FDA on “Drug-Drug Interaction Assessment of Therapeutics Proteins” is now available in DIDB Resource Center. Please note that you must be signed in to access.

For your information, in addition to small molecules, DIDB also contains drug-drug interaction data for therapeutic proteins extracted from literature and FDA biological license applications (BLAs).

Data entry for drug therapies approved by FDA in 2019 is now complete. Among the 48 drugs (38 NDAs and 10 BLAs) approved last year, 39 (33 NDAs and 6 BLAs) have relevant in vitro and clinical findings related to DDI, PGx, food effect, and/or organ impairment. Drug monographs are also available, summarizing key DDI results, QT, and PK information.

The full list of NDA/BLAs entered in DIDB can be found at https://didb.druginteractionsolutions.org/resources/all-ndas/

Do not hesitate to contact us with comments or suggestions.

New finalized In Vitro & Clinical Drug Interaction Studies FDA guidances (January 2020) are now available in the DIDB Resource Center. Please note that you must be signed in to access.

The lists of sensitive substrates, inhibitors, and inducers have been updated and are available in the Resource Center.

Note that we are working on improving the consistency of the presentation so you may notice small changes in some of the drug names or therapeutic classes. Also, for the same reason, we are now presenting all changes in exposure as AUC ratios.

Finally, you will find a new Excel file, combining all the information, so that you can search easily using any of the headings (drug name, therapeutic class, CYP…). Any feedback on this new combined file is welcome!

As always, feel free to contact us if you have any questions or comments.

We have changed our domain to match our new name of UW Drug Interaction Solutions. We feel this name change better reflects our expanding activities and offerings.

All old bookmarks and links will still work, they will be redirected to the same page on our new domain.

If you have any questions or issues please contact us.

As always, don’t forget to check us out and follow us on Linked.

The posters presented at the 12^th International ISSX Meeting in Portland by the DIDB team are now available in the Resource Center’s DIDB Team’s Most Recent Communications section:

• “Main mechanisms of PK DDIs triggering label recommendations for drugs approved by FDA in 2018” (Dr. Jingjing Yu et al.)

• “Variability of OATP1B1/1B3 in vitro inhibition constants and the resulting impact on clinical evaluation” (Dr. Savannah McFeely et al.)

We will be updating the homepage and the public content of our website over the coming few weeks, with an early version released next week. Our new program name, UW Drug Interaction Solutions, reflects our expanding activities and offerings. You can view/download a new brochure and technical flyers on our redesigned homepage.

Note that once you have logged in, the web pages dedicated to subscribers have not changed and you will find all the queries, functions, and editorial content you are used to.

We have also launched a LinkedIn page for UW Drug Interaction Solutions where you can find the most recent news and events regarding the program.

The poster presented by Dr. Jingjing Yu at the 2018 Asia Pacific ISSX meeting entitled “ANALYSIS OF IN VITRO TO IN VIVO PREDICTIONS OF TRANSPORTER-MEDIATED INHIBITION DRUG INTERACTIONS FOR DRUGS APPROVED BY THE US FOOD AND DRUG ADMINISTRATION BTEWEEN 2013 AND 2016” is now available in the DIDB Resource Center.