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)

• Swallowability of Solid Oral Drug Products in Regulatory Submissions: Patient-Specific Features, Product Physical Attributes, and Clinical Swallowability Study Designs

  Mcguire, Meredith; Mostofa, Agm; Shon, Jihong; Frost, Mitchell; Kim, Myong Jin; Li, Karen

• 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

• Development of An In Vitro Permeation Test Method for Rectal Suppositories

  Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam; Shen, Jie

• Using Partial AUC to Characterize the Impact of Shape of Pharmacokinetic Profiles on Bioequivalence Evaluation

  Das, Sharmila; Wu, Fang; Fang, Lanyan; Polli, James

• 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

• 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

• Development of In Vitro-In Vivo Correlation for Long Acting Injectible Microsphere Formulations

  Shahraz, Azar; Mullin, James; Lukacova, Viera; Bolger, Michael; Woltosz, Walt

• Population Pharmacokinetic Analysis of Dabigatran in Bioequivalence Studies

  Sales, Gonzalez; Fang, Lanyan; Zhao, Liang

• 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