Data Curation and Entry in DIDB – June Summary

In June, we added 112 citations in DIDB, including 28 in vitro and 84 in vivo articles (47 articles published in June 2021), as well as 2 recently approved NDAs. You can check the citations that are recently published and entered in DIDB, here, and all the NDAs/BLAs, here.

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

June newsletter

The June Newsletter is now available. You can see this and past newsletters (published in 2020 and 2021) in the DIDB Resource Center. This is our last issue as you can now access the latest citations using our new citations search on the DIDB Home page. Please note that you must be signed in to access.

Do not hesitate to contact us with comments or suggestions.

Continued Education Course on Drug Interactions

Senior team members, Dr Jingjing Yu and Dr Cathy Yeung, are instructing a CE course on Principles & Mechanisms of Pharmacokinetic Drug-Drug Interactions for Recently Approved Drugs which provides pharmaceutical scientists and clinical pharmacists with an in-depth understanding of the mechanisms of drug interactions.

This 5-session course was prepared in collaboration with University of Wisconsin-Madison.

To learn more and register, visit here.

FDA Draft Guidance Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents

The draft guidance newly released by FDA on “Evaluation go Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical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This draft guidance describes FDA’s recommendations regarding: (1) when clinical DDI studies with acid-reducing agents are needed; (2) the design of clinical DDI studies; (3) how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FDA Draft Guidance for Clinical Drug Interaction Studies with Combined Oral Contraceptives

The draft guidance newly released by FDA on “Clinical Drug Interaction Studies Combined with Oral Contraceptives” is now available in DIDB Resource Center.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.