A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation
- 23 February 2022
- journal article
- research article
- Published by Elsevier in Journal of Pharmaceutical Sciences
- Vol. 111 (6) , 1820-1832
Abstract
No abstract availableKeywords
This publication has 31 references indexed in Scilit:
- Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release TabletsMolecular Pharmaceutics, 2016
- Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug ApplicationsThe AAPS Journal, 2016
- Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage FormsThe AAPS Journal, 2016
- Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?The AAPS Journal, 2015
- Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design ParadigmThe AAPS Journal, 2015
- PBPK models for the prediction of in vivo performance of oral dosage formsEuropean Journal of Pharmaceutical Sciences, 2014
- Dissolution Testing for Generic Drugs: An FDA PerspectiveThe AAPS Journal, 2011
- Computer simulations using GastroPlus™ to justify a biowaiver for etoricoxib solid oral drug productsEuropean Journal of Pharmaceutics and Biopharmaceutics, 2009
- Impact of the intragastric location of extended release tablets on food interactionsJournal of Controlled Release, 2005
- Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European UnionEuropean Journal of Pharmaceutical Sciences, 2002