Author:
Cedarbaum Jesse M.,Stephenson Diane,Rudick Richard,Carrillo Maria C.,Stebbins Glenn,Kerr Douglas,Heemskerk Jill,Galpern Wendy R.,Kaufmann Petra,Cella David,Isaac Maria,Walton Marc K.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Clinical Neurology,Pharmacology
Reference26 articles.
1. Cuthbert BN. The RDoC framework: facilitating transition from ICD/DSM to dimensional approaches that integrate neuroscience and psychopathology. World Psychiatry 2014;13:28-35
2. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. U.S. Department of Health and Human Services, Food and Drug Administration, 2009
3. Concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias EMA/CHMP/617734/2013.
4. Isaac M, Vamvakas S, Abadie E, Jonsson B, Gispen C, Pani L. Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid relat-ed biomarkers for drugs affecting amyloid burden—regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials. Eur Neuropsychopharmacol. 2011;21:781-788.
5. Stephenson DT, Avilas A, Bain LJ, et al. Coalition Against Major Diseases: Precompetitive collaborations and regulatory paths to accelerating drug development for neurodegenerative diseases. Ther Innov Regulat Sci 2013;47:632-638.
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