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(138)
• Posters(42)
• Presentations(65)
• Papers(31)

• 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

• 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

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

  Mullin, James; Van Osdol, William; 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

• Population Pharmacokinetic Modeling for Fluticasone Propionate and Salmeterol Xinafoate Inhalation Powder in a Bioequivalence Study

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Joga

• EVALUATING NOVEL PILOT PHARMACOKINETIC BIOEQUIVALENCE STUDY FOR INHALATION POWDER DRUG PRODUCTS EXHIBITING BATCH-TO-BATCH VARIABILITY

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Joga