Yes, modeling and simulation data that are performed in lieu of clinical studies are included.
Archives: FAQs
What are the differences between a DIDB citation and an entry?
A citation is either a publication or an NDA/BLA review and often contains multiple in vitro and/or clinical studies. An in vitro study refers to an experiment, which may contain one or multiple entries, whereas a clinical study may have one of multiple experiments and each experiment entered in DIDB is referred to as an entry.
What are the main mechanisms of DDI covered in DIDB?
DIDB includes mainly metabolism- and transporter-based pharmacokinetic interactions. However, other mechanisms (e.g. absorption-based DDIs, pharmacogenetics, food effects, hepatic and renal impairment,…) are also covered. Pharmacodynamic interactions which cannot be explained by changes in drug or metabolite exposure are not included.
Who is curating the information?
All of the DIDB editorial work is conducted in-house, within the Drug Interaction Solutions team at Certara. Our team is comprised of pharmaceutical scientists, pharmacists, and physicians with expertise in drug metabolism, transport, pharmacokinetics, drug interactions, and clinical pharmacology.
How often is DIDB updated?
Daily. As soon as the DIDB entries have been reviewed and validated, they become available to subscribers immediately.
Is there transporter induction data in DIDB?
Currently in vitro transporter induction data is not included, but we are working on adding this module in the future when experimental protocols are well standardized and guidance from regulatory agencies is available. However, clinical transporter DDIs involving transporter induction are included in DIDB.
If the data is not clear or contradictory within a publication, how is the data presented?
When information from an article or an NDA review is unclear, we check additional sources (e.g. clinicaltrials.gov for clinical DDI studies) or reach out to the authors of the article for clarification. Most of the time, we add comments within DIDB entries to explain possible discrepancies.
How do you choose the most relevant publications to enter and how do you guarantee coverage of relevant literature?
DIDB has detailed processes that have been developed over the last 20 years to ensure the most relevant data is captured in an unbiased manner by our curation process. The DIDB editorial team manually reviews the most relevant scientific journals, performs queries of NCBI PubMed, and verifies that relevant cited data are entered as well.
Is data from non-English publications included in DIDB?
Most scientific publications are in English; therefore, the majority of data available in DIDB is from publications in English. However, some articles in DIDB are in other languages when published in native language of one of the team members, or when the (English) abstract provides sufficient information to include.
What is the literature source?
The data come from the scientific literature and the NDA reviews of the FDA-approved products. The majority of articles are indexed by NCBI PubMed; however, some articles are obtained from Embase. Articles must be published in print or included in a finalized version of its respective online only journal issue in order for the data to be included in DIDB. Relevant online ahead of print articles included in PubMed or Embase are included in DIDB only after a print version is published.