In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

Autor Forbes, Ben, Bäckman, Per, Christopher, David, Dolovich, Myrna, Li, Bing V., Morgan, Beth
Vydáno v AAPS J (2015)

A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution

Autor Weber, Benjamin, Lee, Sau L., Lionberger, Robert, Li, Bing V., Tsong, Yi, Hochhaus, Guenther
Vydáno 2013

Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies

Autor Tampal, Nilufer, Mandula, Haritha, Zhang, Hongling, Li, Bing V., Nguyen, Hoainhon, Conner, Dale P.
Vydáno v AAPS PharmSciTech (2014)

Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing

Autor Weber, Benjamin, Lee, Sau L., Delvadia, Renishkumar, Lionberger, Robert, Li, Bing V., Tsong, Yi, Hochhaus, Guenther
Vydáno v AAPS J (2014)

Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval

Autor Li, Bing V., Jin, Feiyan, Lee, Sau L., Bai, Tao, Chowdhury, Badrul, Caramenico, Hoainhon T., Conner, Dale P.
Vydáno 2013

In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases

Autor Lee, Sau Lawrence, Adams, Wallace P., Li, Bing V., Conner, Dale P., Chowdhury, Badrul A., Yu, Lawrence X.
Vydáno 2009

Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

Autor 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.
Vydáno 2012

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

Autor 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.
Vydáno v AAPS J (2015)