Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective von Newman, Bryan, Babiskin, Andrew, Bielski, Elizabeth, Boc, Susan, Dhapare, Sneha, Fang, Lanyan, Feibus, Katharine, Kaviratna, Anubhav, Li, Bing V, Luke, Markham C, Ma, Tian, Spagnola, Michael, Walenga, Ross L, Wang, Zhong, Zhao, Liang, El-Gendy, Nashwa, Bertha, Craig M, Abd El-Shafy, Mohammed, Gaglani, Dhaval K

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Mechanistic modeling of generic orally inhaled drug products: A workshop summary report von Walenga, Ross L., Butler, Clare, Craven, Brent A., Longest, P. Worth, Mohamed, Raja, Newman, Bryan, Olsson, Bo, Hochhaus, Günther, Li, Bing V., Luke, Markham C., Zhao, Liang, Przekwas, Andrzej, Lionberger, Robert

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

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In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches von Forbes, Ben, Bäckman, Per, Christopher, David, Dolovich, Myrna, Li, Bing V., Morgan, Beth

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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances von Lu, Dongmei, Rege, Bhagwant, Raw, Andre, Yang, Jingyue, Alam, Khondoker, Bode, Chris, Zhao, Liang, Faustino, Patrick, Wu, Fang, Shakleya, Diaa, Nickum, Elisa, Li, Bing V., Wang, Rong, Stier, Ethan, Miezeiewski, Blair, Patel, Rachana, Boam, Ashley, Lionberger, Robert, Keire, David, Yu, Lawrence

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Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective von El-Gendy, Nashwa, Bertha, Craig M, Abd El-Shafy, Mohammed, Gaglani, Dhaval K, Babiskin, Andrew, Bielski, Elizabeth, Boc, Susan, Dhapare, Sneha, Fang, Lanyan, Feibus, Katharine, Kaviratna, Anubhav, Li, Bing V, Luke, Markham C, Ma, Tian, Newman, Bryan, Spagnola, Michael, Walenga, Ross L, Zhao, Liang

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Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective von Liu, Qing, Absar, Mohammad, Saluja, Bhawana, Guo, Changning, Chowdhury, Badrul, Lionberger, Robert, Conner, Dale P., Li, Bing V.

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Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products von Wang, Rong, Conner, Dale P., Li, Bing V.

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International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences von Lu, Dongmei, Lee, Sau L., Lionberger, Robert A., Choi, Stephanie, Adams, Wallace, Caramenico, Hoainhon N., Chowdhury, Badrul A., Conner, Dale P., Katial, Rohit, Limb, Susan, Peters, John R., Yu, Lawrence, Seymour, Sally, Li, Bing V.

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Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval von Li, Bing V., Jin, Feiyan, Lee, Sau L., Bai, Tao, Chowdhury, Badrul, Caramenico, Hoainhon T., Conner, Dale P.

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Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies von Tampal, Nilufer, Mandula, Haritha, Zhang, Hongling, Li, Bing V., Nguyen, Hoainhon, Conner, Dale P.

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In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases von Lee, Sau Lawrence, Adams, Wallace P., Li, Bing V., Conner, Dale P., Chowdhury, Badrul A., Yu, Lawrence X.

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Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing von Weber, Benjamin, Lee, Sau L., Delvadia, Renishkumar, Lionberger, Robert, Li, Bing V., Tsong, Yi, Hochhaus, Guenther

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A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution von Weber, Benjamin, Lee, Sau L., Lionberger, Robert, Li, Bing V., Tsong, Yi, Hochhaus, Guenther

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FDA Bioequivalence Standards von Yu, Lawrence X, Li, Bing V

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Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report von O'Connor, Dennis, Adams, Wallace P, Chen, Mei-Ling, Daley-Yates, Peter, Davis, John, Derendorf, Hartmut, Ducharme, Murray P, Fuglsang, Anders, Herrle, Myra, Hochhaus, Günther, Holmes, Susan M, Lee, Sau L, Li, Bing V, Lyapustina, Svetlana, Newman, Stephen, Oliver, Martin, Patterson, Beverley, Peart, Joanne, Poochikian, Guirag, Roy, Partha, Shah, Tushar, Singh, Gur Jai Pal, Sharp, Sandra Suarez

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Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration von Li, Bing V., Davit, Barbara M., Lee, Christina H., Pabba, Santhosh K., Mahadevan, Chitra, Caramenico, Hoainhon T., Haidar, Sam H, Sanchez, Aida L., Sigler, Aaron W., Stier, Ethan M., Conner, Dale P.

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Bioequivalence History von Yu, Alex, Sun, Duxin, Li, Bing V., Yu, Lawrence X.

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Bioequivalence for Orally Inhaled and Nasal Drug Products von Saluja, Bhawana, Li, Bing V., Lee, Sau L.

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Bioequivalence for Narrow Therapeutic Index Drugs von Jiang, Wenlei, Yu, Lawrence X.

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