Article
PBPK Modeling of Esomeprazole to Support Adolescent Pharmacokinetic Extrapolation and Label Extension in Chinese Patients With Gastroesophageal Reflux Disease (GERD).
Journal of clinical pharmacology - 1 Aug 2026
Jin Yuwen, Ding Junjie, Hua Xiaohan, Duan Wei, Chen Mo, Zhou Zhaohui, Pandherpur Ramesh V, Dong Jin, Pradeep Sharma, Ma Peiming, Tang Weifeng, Zhou Diansong
Abstract excerpt
Esomeprazole, a proton pump inhibitor (PPI), is widely approved for gastroesophageal reflux disease (GERD) in adults and pediatrics globally, but prior to December 2022, its oral tablets (20 and 40 mg) were approved only for adults in China. To address unmet needs in Chinese adolescents aged 12-17 years, physiologically based pharmacokinetic (PBPK) modeling was employed to extrapolate data and support label...
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