US, EU, and Japanese Regulatory Guidelines for Development of Drugs for Treatment of Alzheimer’s Disease: Implications for Global Drug Development-Reference-Cited by-同舟云学术

US, EU, and Japanese Regulatory Guidelines for Development of Drugs for Treatment of Alzheimer’s Disease: Implications for Global Drug Development

Published:2020-03-03 Issue:4 Volume:13 Page:652-664
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Morant Anne Vinther¹,Vestergaard Henrik Tang²,Lassen Anders Blædel³,Navikas Vaidrius⁴

Affiliation:

1. Regulatory Science & Advocacy H. Lundbeck A/S Copenhagen Denmark

2. Regulatory Strategy H. Lundbeck A/S Copenhagen Denmark

3. Patient Insights H. Lundbeck A/S Copenhagen Denmark

4. Medical Affairs H. Lundbeck A/S Copenhagen Denmark

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12755

Reference44 articles.

1. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website.. Accessed September 10 2019.

2. ICH Harmonized Guideline.General principles for planning and design of Multi‐Regional Clinical Trials. E17 (2017).

3. CHMP Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease. CPMP/EWP/553/95 Rev. 2 (2018).

4. US Food and Drug Administration (FDA). Draft Guidance for Industry.Early Alzheimer’s Disease: Developing Drugs for Treatment(2018).

5. Ministry of Health Labour and Welfare and The University of Tokyo Hospital.Issues to Consider in the Clinical Evaluation and Development of Drugs for Alzheimer’s Disease(2017).

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