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

Author:

Heimbach Tycho,Kesisoglou Filippos,Novakovic Jasmina,Tistaert Christophe,Mueller-Zsigmondy MartinORCID,Kollipara SivacharanORCID,Ahmed Tausif,Mitra Amitava,Suarez-Sharp Sandra

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference30 articles.

1. The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry,2020

2. Applications of clinically relevant dissolution testing: workshop summary report;Suarez-Sharp;AAPS J,2018

3. Regulatory experience with In Vivo In Vitro Correlations (IVIVC) in new drug applications;Suarez-Sharp;AAPS J,2016

4. Translational modeling strategies for orally administered drug products: academic, industrial and regulatory perspectives;Suarez-Sharp;Pharm Res,2020

5. Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link-a workshop summary report;Heimbach;AAPS J,2019

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