Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape-Reference-Cited by-同舟云学术

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape

Published:2013-12-21 Issue:1 Volume:15 Page:237-251
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Alsante Karen M.,Huynh-Ba Kim C.,Baertschi Steven W.,Reed Robert A.,Landis Margaret S.,Furness Scott,Olsen Bernard,Mowery Mark,Russo Karen,Iser Robert,Stephenson Gregory A.,Jansen Patrick

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/content/pdf/10.1208/s12249-013-0061-z.pdf

Reference82 articles.

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2. United States Pharmacopeia and National Formulary (USP 36-1159NF 31). Rockville, MD: United States Pharmacopeia Convention; 2013.

3. United States Government. Title 21—Food and Drugs Section 330.1: general conditions for general recognition as safe, effective and not misbranded. Code of Federal Regulations (annual edition); 2011.

4. United States Pharmacopeial Convention. Key Issue: Monograph Modernization. 2012. Available from: http://www.usp.org/usp-nf/key-issues/monograph-modernization . Accessed 2013

5. United States Pharmacopeial Convention. Pharmacopeial Forum (PF). Available from: http://www.usp.org/usp-nf/pharmacopeial-forum . Accessed 2013

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