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Epilepsia
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October 19, 2022
Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study
Lanyan Fang, Zhichuan Li, Minori Kinjo, et al.
Pharmaceutical Research
|
June 3, 2025
Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use
Lanyan Fang, Eleftheria Tsakalozou, Fang Wu, et al.
The AAPS Journal
|
January 2, 2016
Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective
Yow-Ming C Wang, Jie Wang, Yuen Yi Hon, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
December 22, 2023
Use of physiologically-based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended-release nifedipine
Ming-Liang Tan, Zongming Gao, Andrew Babiskin, et al.
Clinical Pharmacology and Therapeutics
|
January 18, 2019
Evaluating Within-Subject Variability for Narrow Therapeutic Index Drugs
Priya Jayachandran, Hideaki Okochi, Lynda A Frassetto, et al.
The AAPS Journal
|
April 8, 2024
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop
Arindom Pal, Fang Wu, Ross Walenga, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
July 24, 2025
Impact of Mechanistic Modeling and Simulation Methodologies on Product-Specific Guidance Development for Non-Orally Administered Drug Products
Steven G Chopski, Ross L Walenga, Ming-Liang Tan, et al.
Clinical and Translational Science
|
October 5, 2025
Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest
Robert Hopefl, Jing Wang, Abhinav Ram Mohan, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
August 23, 2024
Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points
Xiaomei Chen, Henrik B Nyberg, Mark Donnelly, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
August 29, 2024
Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods
Henrik Bjugård Nyberg, Xiaomei Chen, Mark Donnelly, et al.
Page
of 7
Search research articles
Search
Showing results (11-20 of 70) with videos related to
Sort By:
Page
of 7
Epilepsia
|
October 19, 2022
Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study
Lanyan Fang, Zhichuan Li, Minori Kinjo, et al.
Pharmaceutical Research
|
June 3, 2025
Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use
Lanyan Fang, Eleftheria Tsakalozou, Fang Wu, et al.
The AAPS Journal
|
January 2, 2016
Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective
Yow-Ming C Wang, Jie Wang, Yuen Yi Hon, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
December 22, 2023
Use of physiologically-based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended-release nifedipine
Ming-Liang Tan, Zongming Gao, Andrew Babiskin, et al.
Clinical Pharmacology and Therapeutics
|
January 18, 2019
Evaluating Within-Subject Variability for Narrow Therapeutic Index Drugs
Priya Jayachandran, Hideaki Okochi, Lynda A Frassetto, et al.
The AAPS Journal
|
April 8, 2024
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop
Arindom Pal, Fang Wu, Ross Walenga, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
July 24, 2025
Impact of Mechanistic Modeling and Simulation Methodologies on Product-Specific Guidance Development for Non-Orally Administered Drug Products
Steven G Chopski, Ross L Walenga, Ming-Liang Tan, et al.
Clinical and Translational Science
|
October 5, 2025
Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest
Robert Hopefl, Jing Wang, Abhinav Ram Mohan, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
August 23, 2024
Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points
Xiaomei Chen, Henrik B Nyberg, Mark Donnelly, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
August 29, 2024
Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods
Henrik Bjugård Nyberg, Xiaomei Chen, Mark Donnelly, et al.
Page
of 7