Tannergren Christer, Arora Sumit, Babiskin Andrew, Borges Luiza, Chatterjee Parnali, Cheng Yi-Hsien, Dallmann André, Govada Anitha, Heimbach Tycho, Hingle Martin, Kollipara Sivacharan, Kotzagiorgis Evangelos, Lindahl Anders, Mackie Claire, Malamatari Maria, Mitra Amitava, Moody Rebecca, Pepin Xavier, Polli James, Raines Kimberly, Rullo Gregory, Sanghavi Maitri, Savkur Rajesh, Singh Rajendra, Sjögren Erik, Suarez-Sharp Sandra, Thomas Sherin, Veerasingham Shereeni, Wei Kevin, Wu Fang, Xu Yunming, Yoon Miyoung, Rege Bhagwant
Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 43183, Sweden.
Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
Mol Pharm. 2025 Jan 6;22(1):5-27. doi: 10.1021/acs.molpharmaceut.4c01148. Epub 2024 Dec 16.
This report summarizes the proceedings for Day 3 of the workshop titled "". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the regulatory agencies perspectives. The presentations, which included several case studies, covered the applications of PBBM in generic drug product development, applications of virtual bioequivalence trials to support formulation bridging and the utility of absorption modeling in clinical pharmacology assessments. In addition, recent progress in the prediction of colon absorption and performance of extended-release drug products was shared. The morning session was concluded by representatives from FDA, ANVISA, MHRA, Health Canada, EMA, and PMDA giving their perspectives on the application of PBBM in regulatory submissions. The afternoon breakout sessions focused on four parallel topics: 1) PBBM in generic drug product development; 2) virtual bioequivalence trials applications; 3) safe space and extrapolation; and 4) regional absorption and modified release PBBM applications. This allowed the participants to engage in in-depth discussions of best practices as well to identify key points of consideration to allow further progress on the applications of PBBM.
本报告总结了题为“”的研讨会第三天的会议议程。这一天聚焦于从创新药和仿制药行业以及监管机构的角度看，基于生理的药代动力学（PBBM）在当前及未来药品质量方面的应用。这些报告，其中包括几个案例研究，涵盖了PBBM在仿制药产品开发中的应用、虚拟生物等效性试验在支持剂型桥接方面的应用以及吸收建模在临床药理学评估中的效用。此外，还分享了结肠吸收预测和缓释药品性能方面的最新进展。上午的会议由来自美国食品药品监督管理局（FDA）、巴西卫生监督局（ANVISA）、英国药品和保健品管理局（MHRA）、加拿大卫生部、欧洲药品管理局（EMA）和日本药品和医疗器械管理局（PMDA）的代表发言，阐述他们对PBBM在监管申报中的应用的看法而结束。下午的分组会议聚焦四个平行主题：1）PBBM在仿制药产品开发中的应用；2）虚拟生物等效性试验应用；3）安全空间和外推法；4）区域吸收和缓释PBBM应用。这使与会者能够深入讨论最佳实践，并确定需要考虑的关键点，以便在PBBM应用方面取得进一步进展。
