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Transporters in Drug Development: Scientific and Regulatory Considerations
Lei Zhang1, Shiew-Mei Huang1, Kellie Reynolds1
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract:
Transporters can affect a drug's pharmacokinetics (PK) by controlling absorption, distribution, and elimination processes. They can also affect a drug's pharmacodynamics (PD) by influencing its access to the site of action. More recently, transporters have become important as drug targets (e.g., urate transporter inhibitors as treatment for gout and sodium/glucose cotransporter-2 inhibitors for treating type 2 diabetes). As such, it is important to consider the role of transporters during drug development.
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