Jun Chen
Alkermes
2 Papers
Jun Chen is an academic researcher from Alkermes. The author has contributed to research in topics: Physiologically based pharmacokinetic modelling & Internal medicine. The author has an hindex of 2, co-authored 2 publications.
Chat about Author
Papers
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Mohamad Shebley,Punam Sandhu,Arian Emami Riedmaier,Masoud Jamei,Rangaraj Narayanan,Aarti Patel,Sheila Annie Peters,Venkatesh Pilla Reddy,Ming Zheng,Loeckie de Zwart,Maud Beneton,Francois Bouzom,Jun Chen,Yuan Chen,Yumi Cleary,Christiane Collins,Gemma L. Dickinson,Nassim Djebli,Heidi J. Einolf,Iain Gardner,Felix Huth,Faraz Kazmi,Feras Khalil,Jing Lin,Aleksandrs Odinecs,Chirag Patel,Haojing Rong,Edgar Schuck,Pradeep Sharma,Shu Pei Wu,Yang Xu,Shinji Yamazaki,Kenta Yoshida,Malcolm Rowland +33 more
TL;DR: This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members.
297
Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.
Tycho Heimbach,Yuan Chen,Jun Chen,Vaishali Dixit,Neil Parrott,Sheila Annie Peters,Italo Poggesi,Pradeep Sharma,Jan Snoeys,Mohamad Shebley,Guoying Tai,Susanna Tse,Vijay V. Upreti,Ying-Hong Wang,Alice Tsai,Binfeng Xia,Ming Zheng,Andy Z. X. Zhu,Stephen D. Hall +18 more
TL;DR: PBPK modeling may be used to support mild impairment study waivers or clinical study design, and may be suitable for predicting the impact of RI on PK of drugs predominantly cleared by metabolism with varying contribution of renal clearance.
87