FDA Draft Guidance Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents

The draft guidance newly released by FDA on “Evaluation go Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications” is now available in DIDB Resource Center. Please note that you must be signed in to access.

This draft guidance describes FDA’s recommendations regarding: (1) when clinical DDI studies with acid-reducing agents are needed; (2) the design of clinical DDI studies; (3) how to interpret study results; and (4) communicating findings in product labeling.

DIDB contains absorption-based drug interaction data. The study results are presented based on the underlying mechanism. For example, there are about 450 entries on pH-dependent drugs interactions in DIDB curated from literature and NDA reviews with detailed information about PK assessment results, study design, population, formulation, dosing, and safety results

FDA Draft Guidance for Clinical Drug Interaction Studies with Combined Oral Contraceptives

The draft guidance newly released by FDA on “Clinical Drug Interaction Studies Combined with Oral Contraceptives” is now available in DIDB Resource Center.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This draft guidance focuses on evaluating the DDI potential of an investigational new drug (i.e., perpetrator) on combined oral contraceptives  (COCs; i.e., victim) during drug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.

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.