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Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions

Yi-Hsien Cheng, Arindom Pal, Rebecca Moody,Tycho Heimbach,Viera Lukacova,Nikunjkumar Patel, Gregory Rullo, Yunming Xu,Tausif Ahmed, Essam Kerwash,Lanyan Fang, Fang Wu

Pharmaceutical Research（2025）

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Key words
drug product development,model master file (MMF),modeling and simulation (M&S),oral dosage form,regulatory submission
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