ReviewThe AAPS journal2013
Drug-drug interaction studies: regulatory guidance and an industry perspective.
Review in The AAPS journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
93 citing papers in PubMed, 240 citations in OpenAlex.
- Pharmacokinetics of polatuzumab vedotin in combination with R/G-CHP in patients with B-cell non-Hodgkin lymphoma.Cancer chemotherapy and pharmacology · 2020Trial
- Pharmacogenetics of artemether-lumefantrine influence on nevirapine disposition: Clinically significant drug-drug interaction?British journal of clinical pharmacology · 2019Trial
- A pharmacokinetic drug-drug interaction study between selexipag and midazolam, a CYP3A4 substrate, in healthy male subjects.European journal of clinical pharmacology · 2017Trial
- Use of a cocktail probe to assess potential drug interactions with cytochrome P450 after administration of belatacept, a costimulatory immunomodulator.British journal of clinical pharmacology · 2017Trial
- Pitavastatin is a more sensitive and selective organic anion-transporting polypeptide 1B clinical probe than rosuvastatin.British journal of clinical pharmacology · 2014Trial
- NCA Assistant: An Open-source R/Shiny Interface for Non-compartmental Pharmacokinetic Analysis, Bioequivalence Testing and Study Planning.The AAPS journal · 2026Article
- Endogenous Biomarkers to Evaluate Transporter-Mediated Drug-Drug Interactions: Current Evidence, Impact on Clinical Pharmacology Strategy, Remaining Gaps, and Future Directions.Journal of clinical pharmacology · 2026Review
- Mol2Image: an enhanced DDI prediction framework leveraging drug molecular descriptors.BMC bioinformatics · 2026Article
- A Generative AI Framework for Pharmacokinetic Clinical Study Report Authoring.Clinical and translational science · 2026Article
- Pharmacovigilance Due Diligence in Drug Development: A Practical Playbook for Risk Identification, Compliance Assessment, and Strategic Decision Making.Drug safety · 2026Review
- Comparison of Human and Canine P-Glycoprotein Substrates at R, P, and H Binding Sites.Journal of veterinary pharmacology and therapeutics · 2026Article
- UGTformer: a pretrained graph transformer model for predicting UDP-glucuronosyltransferase-mediated drug metabolism.Journal of cheminformatics · 2026Article
- Machine learning models for drug-drug interaction prediction from computational discovery to clinical application.NPJ digital medicine · 2026Review
- Closing the loop: human-augmented, mechanistically enhanced AI for proactive management of drug-drug interactions.Frontiers in pharmacology · 2026Article
- Method development and validation for simultaneous analysis of four bile acids as CYP3A drug-drug interaction biomarkers.Bioanalysis · 2025Article
- Article
- PS3N: leveraging protein sequence-structure similarity for novel drug-drug interaction discovery.Scientific reports · 2025Article
- Evaluation of potential drug-drug interactions and its determinants among outpatient prescriptions in six community chain pharmacies in Asmara, Eritrea: a cross-sectional study.Scientific reports · 2025Article
- In Vitro Evaluation of Drug-Drug Interaction Between Gliclazide and Antacids at the Absorption Level.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Non-nutritive sweeteners in food-drug interactions: An overview of current evidence.Molecular pharmacology · 2025Review
33 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.