Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases-Reference-Cited by-同舟云学术

Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases

Published:2022-12 Issue:S2 Volume:62 Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Qosa Hisham¹,Hassan Hazem E.²³,Younis Islam R.⁴^ORCID

Affiliation:

1. Bristol Myers Squibb Princeton New Jersey USA

2. Regeneron Pharmaceuticals, Inc. Tarrytown New York USA

3. Department of Pharmaceutical Sciences School of Pharmacy University of Maryland Baltimore Baltimore Maryland USA

4. Department of Clinical Pharmacology Gilead Sciences Inc. Foster City California USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2167

Reference12 articles.

1. H.R.5238 ‐ 97th Congress (1981‐1982): Orphan Drug Act. (1983 January 4).https://www.congress.gov/bill/97th‐congress/house‐bill/5238. Accessed January 5 2022.

2. US Food and Drug Administration.Developing Products for Rare Diseases & Conditions.https://www.fda.gov/industry/developing‐products‐rare‐diseases‐conditions. Accessed May 1 2022.

3. How many rare diseases are there?

4. Rare diseases, common challenges

5. From scientific discovery to treatments for rare diseases – the view from the National Center for Advancing Translational Sciences – Office of Rare Diseases Research

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