The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline Development-Reference-Cited by-同舟云学术

The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline Development

Published:2015-01 Issue:1 Volume:49 Page:197-204
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Gautam Yvonne,Bjerrum Ole J.,Schmiegelow Merete

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/10.1177/2168479014543699.pdf

Reference42 articles.

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2. Bjerrum OJ, Gautam Y, Honore PH, Vana V. Drug-drug combinations revisited. Eur J Hosp Pharm. 2014;21:8–12.

3. US Food and Drug Administration. Guidance for Industry: nonclinical safety evaluation of drug or biologic combinations. http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0004-gdl0002.pdf. Published 2006. Accessed March 18, 2014.

4. US Food and Drug Administration. Code of Federal Regulations Title 21, 21CFR3.2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=3.2. Published 2013. Accessed March 19, 2014.

5. European Medicines Agency. Guideline on the non-clinical development of fixed combinations of medicinal products [EMEA/CHMP/SWP/258498/2005]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003976.pdf. Published 2008. Accessed March 19, 2014.

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