GDUFA Research Outcomes
QCP Methods
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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
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Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space
Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu
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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
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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
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The development of a novel measure for subject by formulation interaction
Pan, Lili; Lionberger, Robert; Zhao, Liang
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Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres
Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael
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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
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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
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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
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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