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.
-
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
-
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
-
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
-
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