Asia‐inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler

• Main Authors: Hong Lu (Author), Lena Klopp‐Schulze (Author), Jatinder Kaur Mukker (Author), Dandan Li (Author), Yoshihiro Kuroki (Author), Jayaprakasam Bolleddula (Author), Nadia Terranova (Author), Kosalaram Goteti (Author), Wei Gao (Author), Rainer Strotmann (Author), Jennifer Dong (Author), Karthik Venkatakrishnan (Author)
• Format: Book
• Published: Wiley, 2024-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract With the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guidelines in effect from 2018, the design of Asia‐inclusive multiregional clinical trials (MRCTs) has been streamlined, thereby enabling efficient simultaneous global de...