How Science Is Driving Regulatory Guidances.
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DOI: 10.1007/978-1-0716-1554-6_19
Abstract: This chapter provides regulatory perspectives on how to translate in vitro drug metabolism findings into in vivo drug-drug interaction (DDI) predictions and how this affects the decision of conducting in vivo DDI evaluation. The chapter… read more here.
Keywords: driving regulatory; science driving; chapter; ddi potential ... See more keywords
Leveraging Physiologically Based Pharmacokinetic Modeling and Experimental Data to Guide Dosing Modification of CYP3A-Mediated Drug-Drug Interactions in the Pediatric Population
Sign Up to like & getrecommendations! Published in 2021 at "Drug Metabolism and Disposition"
DOI: 10.1124/dmd.120.000318
Abstract: Solithromycin is a novel fluoroketolide antibiotic that is both a substrate and time-dependent inhibitor of CYP3A. Solithromycin has demonstrated efficacy in adults with community-acquired bacterial pneumonia and has also been investigated in pediatric patients. The… read more here.
Keywords: cyp3a mediated; based pharmacokinetic; cyp3a; ddi potential ... See more keywords