Literature DB >> 25829266

The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

Manuel Haas1, Valentina Mantua2, Marion Haberkamp3, Luca Pani4, Maria Isaac5, Florence Butlen-Ducuing5, Spiros Vamvakas5, Karl Broich6.   

Abstract

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

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Year:  2015        PMID： 25829266     DOI： 10.1038/nrd4585

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  1 in total

1.  Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.

Authors:  Maria Isaac; Spiros Vamvakas; Eric Abadie; Bertil Jonsson; Christine Gispen; Luca Pani
Journal:  Eur Neuropsychopharmacol       Date:  2011-09-07       Impact factor: 4.600
  1 in total
  5 in total

1.  The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration To Accelerate Diagnosis and Treatment of Traumatic Brain Injury.

Authors:  Geoffrey T Manley; Christine L Mac Donald; Amy J Markowitz; Diane Stephenson; Ann Robbins; Raquel C Gardner; Ethan Winkler; Yelena G Bodien; Sabrina R Taylor; John K Yue; Lakshmi Kannan; Allison Kumar; Michael A McCrea; Kevin K Wang
Journal:  J Neurotrauma       Date:  2017-06-27       Impact factor: 5.269

2.  Higher FT4 or TSH below the normal range are associated with increased risk of dementia: a meta-analysis of 11 studies.

Authors:  Yue Wu; Yuqing Pei; Fei Wang; Danfei Xu; Wei Cui
Journal:  Sci Rep       Date:  2016-08-25       Impact factor: 4.379

3.  The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.

Authors:  Diane Stephenson; Derek Hill; Jesse M Cedarbaum; Maria Tome; Spiros Vamvakas; Klaus Romero; Daniela J Conrado; David T Dexter; John Seibyl; Danna Jennings; Timothy Nicholas; Dawn Matthews; Zhiyong Xie; Syed Imam; Paul Maguire; David Russell; Mark Forrest Gordon; Glenn T Stebbins; Ed Somer; Jill Gallagher; Arthur Roach; Peter Basseches; Donald Grosset; Kenneth Marek
Journal:  J Parkinsons Dis       Date:  2019       Impact factor: 5.568

Review 4.  Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?

Authors:  Diane Stephenson; Cecile Ollivier; Roberta Brinton; Jeffrey Barrett
Journal:  Clin Pharmacol Ther       Date:  2022-02-07       Impact factor: 6.903

Review 5.  Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.

Authors:  Stephen P Arnerić; Richard Batrla-Utermann; Laurel Beckett; Tobias Bittner; Kaj Blennow; Leslie Carter; Robert Dean; Sebastiaan Engelborghs; Just Genius; Mark Forrest Gordon; Janice Hitchcock; June Kaplow; Johan Luthman; Richard Meibach; David Raunig; Klaus Romero; Mahesh N Samtani; Mary Savage; Leslie Shaw; Diane Stephenson; Robert M Umek; Hugo Vanderstichele; Brian Willis; Susan Yule
Journal:  J Alzheimers Dis       Date:  2017       Impact factor: 4.472
  5 in total

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