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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...

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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:
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
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author 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
author_facet 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
author_sort Romero, Klaus
collection PubMed
description 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.
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spelling pubmed-65103712019-05-20 Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease 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 Clin Transl Sci Research 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. John Wiley and Sons Inc. 2019-03-18 2019-05 /pmc/articles/PMC6510371/ /pubmed/30706986 http://dx.doi.org/10.1111/cts.12619 Text en © 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
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
Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
title Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
title_full Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
title_fullStr Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
title_full_unstemmed Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
title_short Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
title_sort molecular neuroimaging of the dopamine transporter as a patient enrichment biomarker for clinical trials for early parkinson's disease
topic Research
url 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
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