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)

• Age Is a Statistically Significant Predictor of the Within Subject Variability in Dabigatran Pharmacokinetics

  Gonzalez-Sales, Mario; Fan, Jianghong; Fang, Lanyan; Hu, Meng; Lionberger, Robert; Zhao, Liang

• Model Based Exposure-Response Analysis of Rivaroxaban to Assess the Adequacy of Current Bioequivalence Limits in Generic New Oral Anticoagulant Drugs

  Gonzalez-Sales, Mario; Mario; Fang, Lanyan; Kim, Myongjin; Zhao, Liang

• Quantitative Modeling and Simulation to Evaluate Alternative Approaches to be Used in COVID-19 Interrupted Bioequivalence Studies

  Gong, Yuqing; Feng, Kairui; Lee, Jieon; Pan, Yuzhuo; Bai, Tao; Li, Bing; Kim, Carol; Yoon, Miyoung; Zhang, Peijue; Fang, Lanyan; Zhao, Liang

• Optimal Study Design To Evaluate The Clinical Response Of Extended Release Formulations Of Methylphenidate (Mph) In A Pediatric Population

  Gomeni, Roberto; Bressolle-Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen

• Use of a clinical response index derived from a PK/PD model to estimate the optimal in vivo release rate of extended release formulations of MPH

  Gomeni, Roberto; Bressolle-Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen

• Meta-analytic Approach to Evaluate Alternative Models for Characterizing the PK Profiles of Extended Release Formulations of MPH

  Gomeni, Roberto; Bressolle-Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen

• Impact of Between-subject, Within-subject and Between-occasion Variability on Therapeutic Success for Narrow Therapeutic Index Drugs: a Bioequivalence Perspective

  Dahmane, Elyes; Gopalakrishnan, Mathangi; Fang, Lanyan; Gobburu, Joga; Ivaturi, Vijay

• Impact of Variability on Therapeutic Success for Drugs with Narrow Therapeutic Index

  Dahmane, Elyes; Gopalakrishnan, Mathangi; Fang, Lanyan; Gobburu, Joga; Ivaturi, Vijay

• Pharmacokinetic Modeling and Simulation of Naltrexone for Extended-release Intramuscular Injectable Suspension to Derive Alternative Bioequivalence Metrics

  Babiskin, Andrew; Fang, Lanyan; Zhao, Liang

• Assessing Whether Partial AUCs are Needed to Demonstrate Bioequivalence for Liposomal Doxorubicin

  Alam, Khondoker; Sharan, Satish; Fang, Lanyan; Jiang, Wenlie; Kim, Myong Jin; Zhao, Liang; Zhang, Lei; Lionberger, Robert