GDUFA Research Outcomes

IR Oral Products

• All(29)
• Posters(10)
• Presentations(14)
• Papers(5)

• Impact of Solubility and Dissolution Performance on Bioequivalence Recommendations for Immediate-Release Locally Acting Gastrointestinal Drug Products for Promoting Affordable Generic Drugs Available to American Public

  Ren, Ping; Yang, Wen Cheng; Choi, So Jung; Zhang, Yi

• Effect of Medium Viscosity on Swelling and Disintegration of Immediate Release Solid Oral Tablet

  Doole, Fatima T; Don, Ranganath W; Poudel, Ishwor; Zhang, Lei; Jiang, Wenlei; Gao, Zongming

• Global Harmonization of Immediate-Release Solid Oral Drug Product Bioequivalence Recommendations and the Impact on Generic Drug Development

  Kotsybar, Joseph; Hakeem, Susan; Zhang, Lei; Jiang, Wenlei

• FDA Perspective on Dissolution Testing for Development of High-Risk Oral Drug Products Containing Amorphous Solid Dispersions

  Zhao, Gang; Wei, Kevin; Nguyen, Duyen; Lim, Hye-Lim; Rege, Bhagwant; Lu, Dongmei; Zhang, Qi

• In Vitro Drug Disintegration and Dissolution Testing of BCS Class I Drug Midodrine Hydrochloride Under Simulated Food-Induced Viscous Conditions

  Don, Ranganath W; Lex, Tim R; Zhang, Lei; Jiang, Wenlei; Gao, Zongming

• Identifying High Drug Load Solid Oral Products with Swallowing-Related Adverse Events for In Vitro Swallowability Testing

  Nguyen, Duyen; Shon, Jihong; Frost, Mitchell; Kim, Myong-Jin; Natarajan, Karthika

• Solid Oral Immediate-Release Drug Product Landscape and Bioequivalence Recommendations

  Kotsybar, Joseph; Hakeem, Susan; Zhang, Lei; Jiang, Wenlei

• The Impact of Cyclodextrin on Fasting and Fed Bioequivalence Studies in Solid Oral Immediate-Release Drug Products

  Kotsybar, Joseph; Zhang, Lei; Jiang, Wenlei

• Evaluation of U.S. FDA Approved Generic Oral Solution Products

  Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei