Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023

Author/s:Tsakalozou, Eleftheria; Gong, Yuqing; Babiskin, Andrew; Hu, Meng; Mousa, Youssef; Walenga, Ross; Wu, Fang; Yoon, Miyoung; Raney, Sam G; Polli, James E.; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

Date:

Journal:The AAPS Journal

DOI:10.1208/s12248-024-00924-8