Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies-Reference-Cited by-同舟云学术

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Published:2021-12 Issue:12 Volume:110 Page:3896-3906
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Heimbach Tycho,Kesisoglou Filippos,Novakovic Jasmina,Tistaert Christophe,Mueller-Zsigmondy Martin^ORCID,Kollipara Sivacharan^ORCID,Ahmed Tausif,Mitra Amitava,Suarez-Sharp Sandra

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference30 articles.

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1. In silico, in situ, in vitro, and in vivo predictive methods for modeling formulation performance;From Current to Future Trends in Pharmaceutical Technology;2024

2. Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives;Journal of Pharmaceutical Sciences;2023-12

3. Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics – a case study and utility in regulatory justifications;Xenobiotica;2023-11-02

4. Approaches to Account for Colon Absorption in Physiologically Based Biopharmaceutics Modeling of Extended-Release Drug Products;Molecular Pharmaceutics;2023-10-30

5. Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary;The AAPS Journal;2023-10-02