1.
Clin Pharmacol Ther
; 105(5): 1148-1155, 2019 05.
Article
in English
| MEDLINE
| ID: mdl-29901216
ABSTRACT
Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. These considerations are of relevance for regulatory and access pathways that strive to address the "evidence vs. access" conundrum.
Subject(s)
Drug Approval/organization & administration , Drugs, Investigational/pharmacology , Health Services Accessibility , Humans , Patient Selection , Risk Assessment , Time Factors
2.
Nat Rev Drug Discov
; 12(9): 647-8, 2013 Sep.
Article
in English
| MEDLINE
| ID: mdl-23989775
3.
Nat Rev Drug Discov
; 12(4): 247-8, 2013 Apr.
Article
in English
| MEDLINE
| ID: mdl-23535921