Yes. This information, extracted from the drug label, is available in the drug monograph PK profile and DDI summary.
PK profile: For drugs that are impacted by food intake, you can find food-related label recommendations under the “Clinical recommended dosage” column using search terms like “food,” “meal,” “fat”, or “empty.” This will generate a list of drugs with specified food intake requirements.
In the DDI summary, this information is typically found in the Key Highlights section, usually in the last paragraph.
Yes. In DIDB you can find if a drug is classified as an NTI drug. This information is available in the drug characteristics table by selecting “clinically significant NTI” in the Effect column. This list of NTI drugs is primarily classified based on information from regulatory agencies, including the EMA, FDA, PMDA, and Health Canada. Additionally, in the DDI Marker Studies Knowledgebase, NTI status is noted for substrate drugs, with references provided from both regulatory agencies and DrugBank.
Total PK data is displayed in DIDB by default. Unbound PK data is provided in brackets, along with the percent change, if the changes in AUC, Cmax, CL, or CLrenal are different from the total PK. Percent changes shown in the query result table and highlighted in the tree view of each citation are based on total PK values.
Yes, DIDB includes data on compounds with relevant in vitro or clinical information, regardless of their marketing status. These compounds may be under clinical investigation, approved outside of the US, or withdrawn from the market.
Acid-reducing agents in DIDB are categorized into three therapeutic classes: Antacids, H-2 Receptor Antagonists, and Proton Pump Inhibitors. To find all drug interaction studies involving acid-reducing agents, navigate to Basic Queries > Therapeutic Class Queries > One Therapeutic Class. Specify the role of acid-reducing agents as either Objects or Precipitants, then select “Antacids”, “H-2 Receptor Antagonists”, or “Proton Pump Inhibitors” in the Therapeutic Class field and choose the desired study condition “in vitro” and/or “in vivo”.
To find studies with percent changes in AUC or CL, go to Advanced queries > AUC-CL Change Queries > with Therapeutic Class. If your focus is solely on absorption-based drug interaction data, select “other mechanism” as the option. All absorption-based DDI studies in DIDB are categorized under other mechanisms and are annotated with specific mechanisms such as binding/chelation, gastrointestinal motility, or pH dependency.
For in vitro data, use the “Enzyme Queries” and “Transporter Queries” to find variants of a polymorphic enzyme or transporter. Enter “variant” in the designated enzyme or transporter field, then select the specific enzyme or transporter. The studied variant is usually listed along with the kinetic parameters (e.g., Km, Vmax, CLint, IC50) or in the comments of each entry.
For clinical data, the “Pharmacogenetics Queries” retrieve information on how polymorphic genes of enzymes and transporters affect drug disposition. The “Search for Citations” query generates a list of citations for a specific compound, gene, or population characteristic. Each citation includes links to pharmacogenetic websites for background information, allowing users to explore specific variants of the polymorphic gene under investigation.
In the “Search for Quantitative Results” query, the selected compound or gene includes hyperlinks at the top of the result page, directing users to dedicated pharmacogenetic or compound websites for further exploration. The result table displays the percent change in various PK parameters based on the genotype investigated and compared to the reference (normal) genotype. Results for specific genotype variants can be refined using the table’s filtering features.
Additionally, for clinical DDI studies performed in populations with different phenotypes or genotypes, the variant information is described in the population field of each entry.
Currently, queries based on Cmax are not available. However, queries for AUC and CL can be performed. Plasma concentration data, such as Cmax values and changes in Cmax, are displayed in the results table when conducting AUC-CL change queries or other pharmacokinetic queries.
Fm, in vivo values, as presented in the PK profiles, are calculated based on the highest change in AUC observed with a strong inhibitor in DDI studies, or as reported in NDA or BLA reviews. These values may sometimes be overestimated due to the possible involvement of other enzymes or transporter pathways that are also inhibited by the precipitant. In such cases, the risk of overestimation is explicitly noted. Discrepancies in fm values may arise due to the selection of a single DDI study (worst case scenario) or the involvement of additional enzymes/transporters.
The fm, in vitro values in DIDB are not calculated by the DIDB Editorial Team. Instead, they are sourced directly from the drug approval packages.
Yes. Oligonucleotide drugs are included in DIDB if relevant data from the literature or drug approval packages are available.