Rajman, Iris, Zhao, Sylvia, HIRANO, MASARU and HONMA, WATARU (2019) Expediting access to medicines in Asia: Recommendations for a new paradigm of global drug development. Drug discovery today. ISSN 1878-5832; 1359-6446

Abstract

Abstract:
Currently, there is a requirement from several health authorities in Asia for Phase 1 data in Asian subjects to allow Asian patients to join global Phase 2/3 trials. Here we discuss inherent limitations in the design of Phase 1 ethnic sensitivity studies (ESS) that make it difficult to identify inter-ethnic differences in the safety/PK profile of investigational drugs. We reviewed dosing data for Japan and China from recent Novartis-sponsored NDAs to critically assess the value of conducting separate Phase 1 ESSs in Asian populations and we propose recommendations for a new paradigm of global drug development. If relevant safety, PK, and PG data are available from the original Phase 1 study population, it may be possible to extrapolate these data to the Asian populations to allow inclusion of Asian patients in Phase 2/3 clinical trials, without conducting a Phase 1 ESS in the new population. If feasible, PK/PG data from the Asian populations could be collected during Phase 2/3 trials of drug development. This approach may help to streamline the drug development in Asia, whilst still addressing the requirements of regulatory agencies.

Item Type:	Article
Keywords:	ethnic sensitivity; drug dose; drug development; Asia
Date Deposited:	18 Feb 2020 00:45
Last Modified:	18 Feb 2020 00:45
URI:	https://oak.novartis.com/id/eprint/41148