Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms-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 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms

Published:2013-11-27 Issue:1 Volume:15 Page:198-212
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Alsante Karen M.,Huynh-Ba Kim,Baertschi Steven W.,Reed Robert A.,Landis Margaret S.,Kleinman Mark H.,Foti Christopher,Rao Venkatramana M.,Meers Paul,Abend Andreas,Reynolds Daniel W.,Joshi Biren K.

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/s12249-013-0047-x.pdf

Reference60 articles.

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2. Parenty ADC, Button WG, Ott MA. An expert system to predict the forced degradation of organic molecules. Molecular Pharmaceutics. 2013;in press.

3. Baertschi SW, Reynolds DW, Jansen P, Alsante K, Santafianos D, Kimmer Smith W, et al. Pharmaceutical stress testing: predicting drug degradation. Second ed. Baertschi SW, Alsante KM, Reed RA, editors: InformaHealth Sciences; 2011. 624 p.

4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals ICH M3 (R2). ICH Harmonized Tripartite Guidelines. 2009.

5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Photosafety Evaluation of Pharmaceuticals S10: Draft ICH Consensus Guideline. ICH Harmonized Tripartite Guidelines. 2013.

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