FDA Guidance for Pharmacokinetics in Patients with Impaired Renal Function

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.

All 2019 NDAs and BLAs now fully curated into DIDB

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.

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.)