作者: Kiyohiko Nakai , Russell Wada , Satofumi Iida , Takehiko Kawanishi , Yoshiaki Matsumoto
DOI: 10.2133/DMPK.DMPK-13-RG-100
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摘要: Summary: Orlistat is used clinically worldwide as anti-obesity drug. It a chemically synthesized hydrogenated derivative of lipstatin and an inhibitor gastric pancreatic lipases. has been found to reduce the absorption dietary fat in gastrointestinal tract. Modeling simulation based on pharmacokinetic/pharmacodynamic analysis becoming increasingly design clinical trials assure that are high quality conducted efficiently. We developed trial model for orlistat Phase III study data. This innovative weight loss includes relationships between dose, changes fecal excretion, loss, also incorporates dropout function. The guided dose-finding strategy allowed long-term outcomes orlistat.