Multi-Regional Clinical Trials, ICH-E17, and Subpopulations

Autor:	Bruce Binkowitz, Bill Wang, Yoko Tanaka
Rok vydání:	2018
Předmět:	medicine.medical_specialty business.industry education Harmonization nervous system diseases Clinical trial Drug development Family medicine Medicine media_common.cataloged_instance cardiovascular diseases European union business media_common
Zdroj:	Biopharmaceutical Applied Statistics Symposium ISBN: 9789811078286
DOI:	10.1007/978-981-10-7829-3_11
Popis:	Drug development has rapidly been globalized, and multi-regional clinical trials (MRCTs) have widely been conducted for the purpose of regulatory filing in multiple regions using the same trial data in inside and outside of ICH (international council of harmonization) regions (Regions considered as ICH are European Union, US, Japan, Canada, and Switzerland).
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::fd7bb6f3691430f0a645ad2e7b0d9c80 https://doi.org/10.1007/978-981-10-7829-3_11 Zobrazit plný text záznamu