FDA position statement “Early Alzheimer's disease: Developing drugs for treatment, Guidance for Industry”-Reference-Cited by-同舟云学术

FDA position statement “Early Alzheimer's disease: Developing drugs for treatment, Guidance for Industry”

Published:2018-12-21 Issue:1 Volume:5 Page:13-19
ISSN:2352-8737
Container-title:Alzheimer's & Dementia: Translational Research & Clinical Interventions
language:en
Short-container-title:Alzheimer's & Dementia: Translational Research & Clinical Interventions

Author:

Sabbagh Marwan N.¹,Hendrix Suzanne²,Harrison John E.³⁴⁵

Affiliation:

1. Cleveland ClinicLou Ruvo Center for Brain HealthLas VegasNVUSA

2. PentaraSalt Lake CityUTUSA

3. Principal Consultant at Metis Cognition LtdKilmingtonUK

4. Alzheimer CenterVUmcAmsterdamThe Netherlands

5. Department of Psychological MedicineInstitute of Psychiatry, Psychology and Neuroscience, King's College LondonLondon

Funder

Keep Memory Alive Foundation

NIH

Publisher

Wiley

Subject

Psychiatry and Mental health,Clinical Neurology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1016/j.trci.2018.11.004

Reference42 articles.

1. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation.Early Alzheimer's Disease: Developing Drugs For Treatment Guidelines for Industry.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf 2018

2. Outcomes assessment in clinical trials of Alzheimer's disease and its precursors: readying for short‐term and long‐term clinical trial needs;Posner H.;Innov Clin Neurosci,2017

3. Alzheimer’s disease drug-development pipeline: few candidates, frequent failures

4. Prospects for effective treatment of the Dementia‐Alzheimer syndrome: A renewed odyssey in search of the Magic Elixir;Khatchaturian Z.S.;J Prev Alzheimers Dis,2017

5. Alzheimer's disease drug development pipeline: 2018

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