Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation

Maximizing the Role of Physiologically Based Oral Absorption Modeling in Generic Drug Development

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1242 ◽

2018 ◽

Vol 105 (2) ◽

pp. 307-309 ◽

Cited By ~ 5

Author(s):

Amitava Mitra

Keyword(s):

Drug Development ◽

Generic Drug ◽

Oral Absorption ◽

Physiologically Based ◽

A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms

Journal of Pharmacokinetics and Pharmacodynamics ◽

10.1007/s10928-021-09778-5 ◽

2021 ◽

Author(s):

Nan-Hung Hsieh ◽

Frédéric Y. Bois ◽

Eleftheria Tsakalozou ◽

Zhanglin Ni ◽

Miyoung Yoon ◽

...

Keyword(s):

Drug Development ◽

Generic Drug ◽

Dosage Forms ◽

Oral Dosage ◽

Modeling Approach ◽

Physiologically Based ◽

Absorption Modeling ◽

Oral Dosage Forms ◽

Development Application

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

Journal of Pharmaceutical Sciences ◽

10.1002/jps.24076 ◽

2014 ◽

Vol 103 (10) ◽

pp. 3263-3275 ◽

Cited By ~ 26

Author(s):

Rodrigo Cristofoletti ◽

Jennifer B. Dressman

Keyword(s):

Generic Drug ◽

Clinical Relevance ◽

Pharmacokinetic Models ◽

Physiologically Based Pharmacokinetic Models ◽

Drug Products ◽

Physiologically Based

Using Physiologically Based Pharmacokinetic (PBPK) Modeling as a Supportive Tool for Risk Assessment on the Critical Quality Attribute of a Generic Drug Product

10.26226/morressier.57d6b2bcd462b8028d88e03d ◽

2016 ◽

Author(s):

Fang Wu

Keyword(s):

Risk Assessment ◽

Generic Drug ◽

Drug Product ◽

Pbpk Modeling ◽

Quality Attribute ◽

Critical Quality Attribute ◽

Generic Drug Product ◽

Physiologically Based

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

The AAPS Journal ◽

10.1208/s12248-010-9250-9 ◽

2011 ◽

Vol 13 (1) ◽

pp. 59-71 ◽

Cited By ~ 81

Author(s):

Xinyuan Zhang ◽

Robert A. Lionberger ◽

Barbara M. Davit ◽

Lawrence X. Yu

Keyword(s):

Drug Development ◽

Quality By Design ◽

Physiologically Based ◽

Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

The AAPS Journal ◽

10.1208/s12248-021-00564-2 ◽

2021 ◽

Vol 23 (2) ◽

Author(s):

Fang Wu ◽

Heta Shah ◽

Min Li ◽

Peng Duan ◽

Ping Zhao ◽

...

Keyword(s):

Modeling And Simulation ◽

Drug Administration ◽

Food And Drug Administration ◽

New Drugs ◽

Physiologically Based ◽

Regulatory Submissions ◽

Absorption Modeling ◽

The U.S

Generic Drug Products and Therapeutic Equivalence

Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition ◽

10.1081/e-ept4-120050280 ◽

2013 ◽

pp. 1753-1757

Keyword(s):

Generic Drug ◽

Therapeutic Equivalence ◽

Drug Products

Assistance from community pharmacists in identifying generic drug products

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/42.9.1936a ◽

1985 ◽

Vol 42 (9) ◽

pp. 1936-1938

Author(s):

Richard Cramer

Keyword(s):

Generic Drug ◽

Community Pharmacists ◽

Drug Products

Impact of differential particle size of fenofibrate nanosuspensions on biopharmaceutical performance using physiologically based absorption modeling in rats

Journal of Drug Delivery Science and Technology ◽

10.1016/j.jddst.2020.102040 ◽

2020 ◽

Vol 60 ◽

pp. 102040

Author(s):

Divisha Jain ◽

Poonam Singh Thakur ◽

Samarth D. Thakore ◽

Sanjaya K. Samal ◽

Arvind K. Bansal

Keyword(s):

Particle Size ◽

Physiologically Based ◽

Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib

The AAPS Journal ◽

10.1208/s12248-016-9957-3 ◽

2016 ◽

Vol 18 (6) ◽

pp. 1464-1474 ◽

Cited By ~ 23

Author(s):

Neil J Parrott ◽

Li J Yu ◽

Ryusuke Takano ◽

Mikiko Nakamura ◽

Peter N. Morcos

Keyword(s):

Gastric Ph ◽

Ph Changes ◽

Physiologically Based ◽

Absorption Modeling ◽

The Impact