Open AccessA framework to guide dose & regimen strategy for clinical drug development
Author(s) -
Sander Oliver,
Magnusson Baldur,
Ludwig Inga,
Jullion Astrid,
Meille Christophe,
Lorand Daniel,
Bornkamp Björn,
Hinder Markus,
Kovacs Steven J.,
Looby Michael
Publication year - 2021
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12701
Subject(s) - multidisciplinary approach , drug development , drug , regimen , risk analysis (engineering) , computer science , simple (philosophy) , intensive care medicine , balance (ability) , medicine , process management , medical physics , management science , pharmacology , business , engineering , surgery , political science , physical therapy , philosophy , epistemology , law
Optimizing new drug therapies remains a challenge for clinical development, despite the use of ever more sophisticated quantitative methodologies. Although conceptually simple, the idea of finding the right treatment at the right dose for the right patient to ensure an appropriate balance of risks and benefits is challenging and requires a multidisciplinary approach. In this paper, we present a framework developed as a tool for organizing knowledge and facilitating collaboration in development teams.