Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation-Reference-Cited by-同舟云学术

Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation

Published:2008-11-26 Issue:1 Volume:6 Page:40-47
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Kovačević Ivan¹,Parojčić Jelena¹,Homšek Irena¹,Tubić-Grozdanis Marija¹,Langguth Peter¹

Affiliation:

1. Medicines and Medical Devices Agency of Serbia, Vojvode Stepe 458, Belgrade, Serbia, Institute of Pharmaceutical Technology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade, Serbia, Galenika, R&D Institute, Batajnicki drum bb, Belgrade, Serbia, and Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg-University Mainz, Staudingerweg 5, D-55099 Mainz, Germany

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/mp800128y

Reference20 articles.

1. FDA/CDER Guidance for industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations, 2003.

2. EMEA/CPMP Note for guidance on the investigation of bioavailability and bioequivalence, 2001.

3. A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals

4. Feasibility of Biowaiver Extension to Biopharmaceutics Classification System Class III Drug Products

Cited by 84 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Biowaiver based on biopharmaceutics classification system: Considerations and requirements;Pharmaceutical Science Advances;2024-12

2. Phys-DAT: A physiologically-based pharmacokinetic model for unraveling the dissolution, transit and absorption processes using PhysPK®;Computer Methods and Programs in Biomedicine;2024-01

3. Computer-aided biopharmaceutical characterization: Gastrointestinal absorption simulation;Computer-Aided Applications in Pharmaceutical Technology;2024

4. Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study;The AAPS Journal;2023-06-29

5. Developing a Formulation Strategy Coupled with PBPK Modeling and Simulation for the Weakly Basic Drug Albendazole;Pharmaceutics;2023-03-23