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# Value in Leveraging Clinical Pharmacology Principles
- URL: https://www.fdaweb.com/value-in-leveraging-clinical-pharmacology-principles/
- Published: 2022-09-27T12:00:00.000Z
- Updated: 2026-09-14T18:00:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152825

Five researchers in CDER’s Office of Clinical Pharmacology say that “leveraging clinical pharmacology principles during drug development and evaluation can fulfill knowledge gaps and help the right patient receive the right drug, at the right dose, at the right time.” Writing in *Clinical and Translational Science*, the researchers say they evaluated the recommendations and information available from select clinical pharmacology studies in the therapeutic product labeling of new molecular entities (NMEs) approved from 2017 to 2019 for both common and rare diseases.

Some 151 NMEs, including 72 orphan and 79 non-orphan drugs, were analyzed for recommendations and information available related to food-drug interaction, drug-drug interaction, renal impairment, hepatic impairment, QT assessment, and human radiolabeled mass balance studies using data collected from the original labeling and other regulatory documents.

The researchers say their analysis showed no significant difference in the recommendations between orphan and non-orphan drugs except for renal impairment-related recommendations.

“Although there was a trend for more labeling recommendations and fewer postmarketing studies and clinical trials for non-orphan drugs,” the study says, “there appeared to be no substantial differences in how these select clinical pharmacology studies are leveraged during the development and approval of orphan and non-orphan drugs.”