Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development-Reference-Cited by-同舟云学术

Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development

Published:2022-09-08 Issue:2 Volume:40 Page:321-336
ISSN:0724-8741
Container-title:Pharmaceutical Research
language:en
Short-container-title:Pharm Res

Author:

Wu Di,Li Min^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Link

https://link.springer.com/content/pdf/10.1007/s11095-022-03373-0.pdf

Reference90 articles.

1. Food and Drug Admistration. The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls https://www.fda.gov/media/142500/download. 2020.

2. Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X. Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link—a workshop summary report. AAPS J. 2019;21(2):29. https://doi.org/10.1208/s12248-019-0298-x.

3. Pepin XJ, Flanagan TR, Holt DJ, Eidelman A, Treacy D, Rowlings CE. Justification of drug product dissolution rate and drug substance particle size specifications based on absorption PBPK modeling for Lesinurad immediate release tablets. Mol Pharm. 2016;13(9):3256–69. https://doi.org/10.1021/acs.molpharmaceut.6b00497.

4. Laisney M, Heimbach T, Mueller-Zsigmondy M, Blumenstein L, Costa R, Ji Y. Physiologically based biopharmaceutics modeling to demonstrate virtual bioequivalence and bioequivalence safe-space for Ribociclib which has permeation rate-controlled absorption. J Pharm Sci 2022;111(1):274–284. doi: https://doi.org/10.1016/j.xphs.2021.10.017.

5. Heimbach T, Kesisoglou F, Novakovic J, Tistaert C, Mueller-Zsigmondy M, Kollipara S, et al. Establishing the bioequivalence safe space for immediate-release oral dosage forms using physiologically based biopharmaceutics modeling (PBBM): case studies. J Pharm Sci. 2021;110(12):3896–906. https://doi.org/10.1016/j.xphs.2021.09.017.

Cited by 15 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. Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling;CPT: Pharmacometrics & Systems Pharmacology;2024-09-02

2. More Than a Gut Feeling─A Combination of Physiologically Driven Dissolution and Pharmacokinetic Modeling as a Tool for Understanding Human Gastric Motility;Molecular Pharmaceutics;2024-07-03

3. PBPK‐led assessment of antimalarial drugs as candidates for Covid‐19: Simulating concentrations at the site of action to inform repurposing strategies;Clinical and Translational Science;2024-07

4. Integrating Clinical Variability into PBPK Models for Virtual Bioequivalence of Single and Multiple Doses of Tofacitinib Modified‐Release Dosage Form;Clinical Pharmacology & Therapeutics;2024-05-26

5. Assessing and mitigating pH-mediated DDI risks in drug development – formulation approaches and clinical considerations;Drug Metabolism Reviews;2024-05-03