Category: News

The final guideline published by the FDA on Assessing the Effects of Food on Drugs in INDs and NDAs is now available in DIDB Resource Center. Please note that you must be signed in to access.

This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002). 

This guideline provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administrated drug products under INDs, to support NDAs, and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act. (21 U.S.C 335).

Note that clinical food effects data are curated by our DIDB Editorial Team. They are entered in DIDB as single drug PK studies with no precipitant. Changes in AUC, CL, and plasma concentrations are calculated for the fed state versus the control fasted state.

In May, we added 74 citations in DIDB, including 29 in vitro (with 15 articles published in May 2022) and 45 in vivo articles (with 32 articles published in May 2022).

One recently approved NDA was also added: Ganaxolone (ZTALMY)

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

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

The first draft guidance newly released by ICH on “Drug Interaction Studies” is now available in DIDB Resource Center. Please note that you must be signed in to access.

The topic about Drug Interactions was endorsed by ICH Assembly in June 2018, and this draft is the first step towards a harmonized guidance.

This Guideline provides general recommendations on how to evaluate the DDI potential of an investigational drug. It is recognized that the DDI evaluation is generally tailored based on the specific drug, intended patient population, and therapeutic context. Alternative approaches can be used if they satisfy the requirements of the applicable statutes and regulations. The focus of the Guideline is the development of new drugs, but if new scientific information regarding the potential for DDIs is obtained after drug approval, additional DDI evaluation should be considered.

The DDI Marker Studies Knowledgebase (replacing the previous combined and individual lists of CYP/P-gp substrates and perpetrators) has been updated and is available in the DIDB Resource Center.

Note, that we have initiated the gradual expansion of the Knowledgebase with more transporter data beyond P-gp. Thus, in this version, you will find data for BCRP and OATP1B1/1B3. More transporter data will be added throughout the year.

In addition to substrates, inhibitors and inducers of CYPs and transporters, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g. dose proportionality accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics

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

2022 marks 20 years of DIDB licensing and the selection by the ASCPT of Dr. René Levy and Dr. Isabelle Ragueneau-Majlessi to receive the 2022 Gary Neil Prize for Innovation in Drug Development.

Read the story here: https://www.washington.edu/news/2022/01/13/uw-pharmacys-drug-interaction-database-built-to-promote-medication-safety-wins-national-innovation-award/

The lists of sensitive substrates, inhibitors, and inducers, including the file combining all lists, have been updated and are available in the DIDB Resource Center.

A total of 18 drug interactions, involving 13 drugs, were added to the October version or were updated. Nine of these drugs were cancer treatments, including 7 kinase inhibitors, being identified as sensitive substrates or perpetrators of CYP enzymes or the P-gp transporter.

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

Our publication Excipient knowledgebase: Development of a comprehensive tool for understanding the disposition and interaction potential of common excipients is now available online on the publisher website (free full text).

The Excipient Knowledgebase is provided as an Excel file and can be downloaded from the Supporting Information section.

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 a list of the latest citations published which have been entered into DIDB (please note that you must be signed in to access).

Do not hesitate to contact us with comments or suggestions.

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.

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