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# Evaluation of Transporter-Mediated DDIs Up: Study
- URL: https://www.fdaweb.com/evaluation-of-transporter-mediated-ddis-up-study/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136162

FDA researchers say that a survey they conducted shows an increasing trend in the evaluation of transporter-mediated drug-drug interactions (DDIs) either during drug development or post-approval. [Writing](Fan%5Fet%5Fal-2016-The%5FJournal%5Fof%5FClinical%5FPharmacology.pdf) in *The Journal of Clinical Pharmacology*, the researchers say that their observation may be a reflection of recent interest in the area of drug transporters encompassing the evaluation of all factors that may affect the safe and effective use of drug products.

“The information obtained from transporter-related postmarketing studies could be critical for dosing optimization in the labeling related to coadministration of the drug product in the presence of other drugs that may modify transporter function,” the article says. “Because a significant lag time in anticipated between drug approval and post-marketing requirement/post-marketing commitment (PMR/PMC) fulfillment, it is detrimental to include transporter assessments as part of the drug development strategy in the clinical drug development programs so that knowledge gained can be used for proper management of therapy at the drug approval and not wait until postmarketing.”

The survey used multiple data sources to collect information on transporter-related PMR/PMC studies between 1/1999 and 5/2015\. The researchers say that 40 study requests were issued for 35 NDAs. As of 5/31/15, 85% of the studies were considered “fulfilled” and 65% resulted in labeling updates. The majority of studies were for drugs in the anti-infective, oncology, and neurology therapeutic areas.