GDUFA Research Outcomes
Generic Substitution
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to considerations impacting substitution with generic products.
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Frequency Of Generic Brittleness In Epilepsy Patients
Das, Sharmila; Tung, Renee; Ting, Tricia; Polli, James
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Bioequivalence Analysis of Lamotrigine Extended-Release (ER) Tablets based on an In Vitro-In Vivo Relationship (IVIVR) Using the Physiologically Based Pharmacokinetic (PBPK) Absorption Model
Chow, Edwin; Zheng, Nan; Qu, Wen; Sun, Dajun; Wen, Hong; Zhang, Xinyuan; Jiang, Wenlei; Zhao, Liang