TY  - JOUR
TI  - Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease.
EP  - 246
SP  - 240
AV  - public
VL  - 12
Y1  - 2019/05//
N1  - This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
https://creativecommons.org/licenses/by/4.0/
IS  - 3
ID  - discovery10076682
N2  - The Critical Path for Parkinson's (CPP) Imaging Biomarker and Modeling and Simulation working groups aimed to achieve qualification opinion by the European Medicines Agency (EMA) Committee for Medical Products for Human Use (CHMP) for the use of baseline dopamine transporter neuroimaging for patient selection in early Parkinson's disease clinical trials. This paper describes the regulatory science strategy to achieve this goal. CPP is an international consortium of three Parkinson's charities and nine pharmaceutical partners, coordinated by the Critical Path Institute.
SN  - 1752-8062
UR  - https://doi.org/10.1111/cts.12619
JF  - Clinical and Translational Science
A1  - Romero, K
A1  - Conrado, D
A1  - Burton, J
A1  - Nicholas, T
A1  - Sinha, V
A1  - Macha, S
A1  - Ahamadi, M
A1  - Cedarbaum, J
A1  - Seibyl, J
A1  - Marek, K
A1  - Basseches, P
A1  - Hill, D
A1  - Somer, E
A1  - Gallagher, J
A1  - Dexter, DT
A1  - Roach, A
A1  - Stephenson, D
A1  - Critical Path for Parkinson's (CPP) Consortium
A1  - Parkinson's Progression Markers Initiative (PPMI)
ER  -