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.
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Risk Factors Related to Relative Bioavailability Studies for Pediatric Products
Guy, Richard
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Application of Quantitative Clinical Pharmacology in the Development of Long-Acting Injectable (LAI) Drug Products
Zhao, Liang
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Assessing Bioequivalence for Generic Extended Release Formulations
Babiskin, Andrew
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Development of an In Vitro Release Testing Method for Vaginal Creams
Yue, Weizhou; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam; Shen, Jie
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Development of An In Vitro Permeation Test Method for Rectal Suppositories
Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam; Shen, Jie
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Using Partial AUC to Characterize the Impact of Shape of Pharmacokinetic Profiles on Bioequivalence Evaluation
Das, Sharmila; Wu, Fang; Fang, Lanyan; Polli, James
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Determination of CYP2D6 Phenotyping for Metoprolol using CYP2D6 Genotype-derived Activity Score: Results from a Prospective, Clinical Trial
Thomas, C D; Monsely, S A; El Rouby, N; Kim, S; Lingineni, K; Langaee, T; Langaee, T; Gong, Y; Johnson, J A; Schmidit, S O; Fyre, R F; Cavallari, L H
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Evaluation of Model-Based Bioequivalence approach for one single sample pharmacokinetic studies
Tardivon, Coralie; Loingeville, Florence; Sharan, Satish; Donnelly, Mark; Feng, Kairui; Sun, Wanjie; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan; Mentre, France; Bertrand, Julie
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Development of In Vitro-In Vivo Correlation for Long Acting Injectible Microsphere Formulations
Shahraz, Azar; Mullin, James; Lukacova, Viera; Bolger, Michael; Woltosz, Walt
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Population Pharmacokinetic Analysis of Dabigatran in Bioequivalence Studies
Sales, Gonzalez; Fang, Lanyan; Zhao, Liang