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

AAPS PharmSciTech. 2014 Feb;15(1):237-51. doi: 10.1208/s12249-013-0061-z. Epub 2013 Dec 21.

Authors

Karen M Alsante¹, Kim C Huynh-Ba, Steven W Baertschi, Robert A Reed, Margaret S Landis, Scott Furness, Bernard Olsen, Mark Mowery, Karen Russo, Robert Iser, Gregory A Stephenson, Patrick Jansen

Affiliation

¹ Pfizer Global Research and Development, Groton, Connecticut, USA.

No abstract available

MeSH terms

Drug Contamination*
Drug Discovery*
Pharmaceutical Preparations*
Safety*

Substances

Pharmaceutical Preparations