Work

Limitations of Subgroup Safety Analyses for Drug–Drug Interaction Evaluation: Insights from the Talazoparib P‐gp Inhibitor Case

Year: 2026

Type: article

Abstract: Impact of concomitant medications (conmeds) on the safety of the investigational agent is often evaluated using subgroup analyses for safety events in patients who received the conmed versus those who did not. Here, we highlight the potential biases and inconclusive results that can arise from such analyses, using talazoparib and P-glycoprotein(P-gp) inhibitors as a case study. Our findings suggest that drug-drug interactions (DDI) dose adjustments should be based on exposure changes rather than safety subgroup analyses.

Source: The Journal of Clinical Pharmacology

DOI: 10.1002/jcph.70201

Authors: Diane Wang, Charvi Nanavati, Derek Z. Yang, Liza DeAnnuntis, Mohamed Elmeliegy

Institution: Pfizer (United States)

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,150