A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2
国际药品监管机构计划参与机构和组织对某些剂型仿制药体内生物等效性研究豁免的监管建议调查(第二部分)
期刊:Journal of Pharmacy and Pharmaceutical Sciences
影响因子:4.3
doi:10.3389/jpps.2025.14721
García-Arieta, Alfredo; Tam, Andrew; Tiseyra, Florencia; Fernandes, Eduardo Agostinho Freitas; Soares, Kelen Carine Costa; Pereira, Raphael Sanches; Potthast, Henrike; Mettke, Katalina; Chang, Ya-Wen; Hsu, Li-Feng; Su, Yu-Lin; Martínez, Zulema Rodríguez; Divinsky, Milly; Blake, Kevin; Braddy, April C; Rodrigues, Clare; Toh, Tiong; Aurela, Erwin Guzman; González, Liliana Carolina Arévalo; Jones, Ben; Kim, So Hee; Ahn, Choongyul; Yun, Eunju; Kuribayashi, Ryosuke; Shimojo, Kohei; Kasuga, Miho; Makino, Junya; Raffel, Joel; van Oudtshoorn, Joy; Tabane, Philda; Alzenaidy, Bader; AlHarbi, Mohammed; Alharf, Adel; BinAjlan, Albatool; Walther, Chantal; Roost, Matthias S; Crane, Christopher; Lee, Kitty