Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010–2015: Implications for Designing a Regulatory Shortcut to New Drug Application-Reference-Cited by-同舟云学术

Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010–2015: Implications for Designing a Regulatory Shortcut to New Drug Application

Published:2017-01 Issue:1 Volume:51 Page:111-117
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Kwon Kyu Chan,Lee Chulung

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479016663263.pdf

Reference26 articles.

1. Harapanhalli R. CMC considerations for the fixed-dose combination drugs. Paper presented at: AAPS Workshop on Challenges in Developing Fixed-dose Combination Oral Solid Dose Products; September 13–14, 2006; Arlington, VA.

2. World Health Organization. Annex 5, Guidelines for registration of fixed-dose combination medicinal products [WHO Technical Report 2]. http://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929_annex5FDCs.pdf. Published 2005. Accessed February 2015.

3. Kararli TT, Sedo K, Bossart J. Fixed-Dose Combinations. Fixed-dose combination products—a review (part 2: Analysis). http://www.drug-dev.com/Main/Back-Issues/FIXEDDOSE-COMBINATIONS-FixedDose-Combination-Produ-673.aspx. Posted April 2014. Accessed March 2015.

4. Pourkavoos N. Unique risks, benefits, and challenges of developing drug-drug combination products in a pharmaceutical industrial setting. Comb Prod Ther. 2012;2:2.

5. European Medicines Agency. EMA/CHMP/281825/20152. Committee for Human Medicinal Products (CHMP). Guideline on clinical development of fixed combination medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/05/WC500186840.pdf. Published May 2015. Accessed March 2016.

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