GDUFA Research Outcomes

QCP Methods

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.

• All(110)
• Posters(37)
• Presentations(56)
• Papers(17)

• Comparison of Robustness and Efficiency of Four Machine Learning Algorithms for Identification of Optimal Population Pharmacokinetic Models

  Sale, Mark; Ismail, Mohamed; Wang, Fenggong; Feng, Kairui; Hu, Meng; Zhao, Liang; Bies, Robert

• Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space

  Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu

• Model-Based Bioequivalence Approach: Robustness to Model Misspecification for Sparse Pharmacokinetic Bioequivalence Studies

  Philipp, Morgane; Tessier, Adrien; Donnelly, Mark; Fang, Lucy; Feng, Kevin; Zhao, Liang; Grosser, Stella; Sun, Guoying; Sun, Wanjie; Mentre, France; Bertrand, Julie

• Development of a Database Containing Clinical Data on Bioequivalence and Relative Bioavailability Studies Conducted in Pediatric Populations

  Pawar, Gopal; Wu, Fang; Zhao, Liang; Fang, Lanyan; Burckart, Gilbert; Feng, Kairui; Mousa, Yousef; Naumann, Franci; Batchelor, Hannah

• Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space

  Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu

• Population Pharmacokinetic/Pharmacodynamic (PKPD) Modeling for Long Acting Injectable(LAI) Products and Statistical Analysis for Bioequivalence(BE) Assessment

  Paul, Prokash; Yoon, Seongkyu; Kim, Namjoon; Trunfio, Nicholas; Handelman, Garry; Kim, Jaeyeon

• The development of a novel measure for subject by formulation interaction

  Pan, Lili; Lionberger, Robert; Zhao, Liang

• Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres

  Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• Development Of An In Vitro Mechanistic Model That Describes Drug Release From Risperidone Long-Acting Injectable Microspheres

  Mullin, James; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• Application of Dissolution Profile Comparison for Gastric pH-Dependent Drug-Drug Interaction Prediction

  Miao, Lei; Wu, Fang; Yang, Xinning; Ramamoorthy, Anuradha; Lee, Sue-Chih; Raines, Kimberly; Zhang, Lei; Seo, Paul