Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039-Reference-Cited by-同舟云学术

Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039

Published:2023-02-14 Issue:1 Volume:25 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Kourentas Alexandros,Gajewska Monika,Lin Wen,Dhareshwar Sundeep S.,Steib-Lauer Caroline,Kulkarni Swarupa,Hirsch Stefan,Heimbach Tycho,Mueller-Zsigmondy Martin

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

https://link.springer.com/content/pdf/10.1208/s12248-023-00787-5.pdf

Reference21 articles.

1. Kostewicz ES, Abrahamsson B, Brewster M, Brouwers J, Butler J, Carlert S, et al. In vitro models for the prediction of in vivo performance of oral dosage forms. Eur J Pharm Sci. 2014;57:342–66. https://doi.org/10.1016/j.ejps.2013.08.024.

2. Kostewicz ES, Aarons L, Bergstrand M, Bolger MB, Galetin A, Hatley O, et al. PBPK models for the prediction of in vivo performance of oral dosage forms. Eur J Pharm Sci. 2014;57:300–21. https://doi.org/10.1016/j.ejps.2013.09.008.

3. Margolskee A, Darwich AS, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, et al. IMI - Oral biopharmaceutics tools project – evaluation of bottom-up PBPK prediction success part 2: an introduction to the simulation exercise and overview of results. Eur J Pharm Sci. 2017;96:610–25. https://doi.org/10.1016/j.ejps.2016.10.036.

4. Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, et al. Applications of physiologically based biopharmaceutics bodeling (PBBM) to support drug product quality: a workshop summary report. J Pharm Sci. 2021;110(2):594–609. https://doi.org/10.1016/j.xphs.2020.10.059.

5. Abend A, Heimbach T, Cohen M, Kesisoglou F, Pepin X, Suarez-Sharp S. Dissolution and translational modeling strategies enabling patient-centric drug product development: the M-CERSI workshop summary report. AAPS J. 2018;20(3):60. https://doi.org/10.1208/s12248-018-0213-x.

Cited by 5 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. Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook;Pharmaceuticals;2024-07-03

2. Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space;The AAPS Journal;2024-06-11

3. Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report;Molecular Pharmaceutics;2024-04-11

4. Review on Favipiravir Application Uses and Adverse Effect During Covid-19;International Journal of Newgen Research in Pharmacy & Healthcare;2023-12-30

5. Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space;Journal of Pharmaceutical Sciences;2023-07