Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease

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 pa...

Descripción completa

Detalles Bibliográficos
Autores principales: Romero, Klaus, Conrado, Daniela, Burton, Jackson, Nicholas, Timothy, Sinha, Vikram, Macha, Sreeraj, Ahamadi, Malidi, Cedarbaum, Jesse, Seibyl, John, Marek, Kenneth, Basseches, Peter, Hill, Derek, Somer, Ed, Gallagher, Jill, Dexter, David T., Roach, Arthur, Stephenson, Diane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6510371/
https://www.ncbi.nlm.nih.gov/pubmed/30706986
http://dx.doi.org/10.1111/cts.12619
Descripción
Sumario: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.

Ejemplares similares