10122 Development of an In Vitro in Vivo Correlation of Itraconazole Spray-Dried Dispersion Tablets by Ana Luisa Coutinho, Asmita Adhikari, James Polli

Get full text

Biomimetic Artificial Membrane Permeability Assay over Franz Cell Apparatus Using BCS Model Drugs by Leonardo de Souza Teixeira, Tatiana Vila Chagas, Antonio Alonso, Isabel Gonzalez-Alvarez, Marival Bermejo, James Polli, Kênnia Rocha Rezende

Get full text

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report by Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao

Get full text

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop by Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao

Get full text

3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration by Hongbing Wang, Paul C. Brown, Edwin C.Y. Chow, Lorna Ewart, Stephen S. Ferguson, Suzanne Fitzpatrick, Benjamin S. Freedman, Grace L. Guo, William Hedrich, Scott Heyward, James Hickman, Nina Isoherranen, Albert P. Li, Qi Liu, Shannon M. Mumenthaler, James Polli, William R. Proctor, Alexandre Ribeiro, Jian‐Ying Wang, Ronald L. Wange, Shiew‐Mei Huang

Get full text