Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities-Reference-Cited by-同舟云学术

Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities

Published:2021-12-20 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Abuasal Bilal¹,Ahmed Mariam A.¹²,Patel Priyank³,Albusaysi Salwa⁴,Sabarinath Sreedharan¹,Uppoor Ramana¹,Mehta Mehul¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Takeda Pharmaceutical US Cambridge Massachusetts USA

3. School of Pharmacy University of Maryland Baltimore Maryland USA

4. Department of Pharmaceutics Faculty of Pharmacy King Abdulaziz University Jeddah Saudi Arabia

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2501

Reference35 articles.

1. Challenges and Opportunities in Rare Disease Drug Development

2. Orphan drug development in the United States;Groft S.C.;CPJ,1985

3. Orphan Drug Act: Public Law 97–414.Sect J (b)(1983).

4. Flexibility in the FDA approach to orphan drug development

5. The Impact of the Orphan Drug Act on the Development and Advancement of Neurological Products for Rare Diseases: A Descriptive Review

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