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.
Category: News
Lists of Sensitive Substrates, Inhibitors and Inducers updated + New Combined List
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 are now druginteractionsolutions.org
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.
ISSX Posters available in the Resource Center
The posters presented at the 12th 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.)
Update of our website to come soon
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.
2018 Asia Pacific ISSX poster presentation available in the Resource Center
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.
Dr. Jingjing Yu to present new NDA data at the upcoming 6th Asia Pacific ISSX Meeting
Dr. Jingjing Yu will be presenting a poster 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” at the upcoming 6th Asia Pacific ISSX Meeting in Hangzhou, China, May 11 – 14, 2018.
The poster will be on display throughout the meeting and poster presentation sessions will be held on Saturday, May 12th and Sunday, May 13th.
New Manuscript in Drug Metabolism and Disposition
Our most recent publication entitled “Risk of Clinically Relevant Pharmacokinetic-based Drug-drug Interactions with Drugs Approved by the U.S. Food and Drug Administration Between 2013 and 2016” by Yu et al. is now available on Drug Metabolism and Disposition online FastForward site (https://dmd.aspetjournals.org). This is an extensive review of the NDA data we analyzed for the DIDB platform, with useful supplemental tables summarizing the main clinical findings.
Do not hesitate to contact us if you have any questions.
New “Overall Effect” for in vivo studies to include absorption-based DDIs
As a result of our continuous efforts to expand the DIDB platform coverage of pharmacokinetic-based drug interactions beyond metabolism and transport, the following new “Overall Effect” categories are now available for in vivo DDI studies:
- In Vivo Other Mechanism >20% Effect
- In Vivo Other Mechanism No Effect
With the following Study subtypes
- pH dependency (absorption)
- Binding/chelation (absorption)
- Gastrointestinal motility (absorption)
- Plasma protein binding displacement (distribution)
- Enzyme down-regulation/up-regulation reversal (metabolism)
- Complex/multifactorial mechanism
As we increase the number of citations pertaining to these mechanisms, you will start seeing these new studies in the queries (dropdown menus) and their results. As a first step, we entered all pH-dependent DDI evaluations (both negative and positive results) with proton pump inhibitors and we will continue adding absorption-based DDIs to the platform during the coming months.
Should you have questions, comments or concerns, please contact us.
New FDA guidance documents on DDIs available in the Resource Center
The two new FDA guidance documents on drug-drug interactions have been added to the “Regulatory Guidances” section of the DIDB Resource Center. Please note that you must be signed in to access.
- Clinical Drug Interaction Studies (Oct. 2017). Draft Guidance
- In Vitro Metabolism- and Transport-Mediated Drug-Drug Interaction Studies (Oct. 2017). Draft Guidance
DIDB Editorial Team