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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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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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. |
format | Online Article Text |
id | pubmed-6510371 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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