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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.
Alsante KM, Huynh-Ba K, Baertschi SW, Reed RA, Landis MS, Kleinman MH, Foti C, Rao VM, Meers P, Abend A, Reynolds DW, Joshi BK. Alsante KM, et al. Among authors: kleinman mh. AAPS PharmSciTech. 2014 Feb;15(1):198-212. doi: 10.1208/s12249-013-0047-x. Epub 2013 Nov 27. AAPS PharmSciTech. 2014. PMID: 24281749 Free PMC article. No abstract available.
Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product.
Baertschi SW, Clapham D, Foti C, Kleinman MH, Kristensen S, Reed RA, Templeton AC, Tønnesen HH. Baertschi SW, et al. Among authors: kleinman mh. J Pharm Sci. 2015 Sep;104(9):2688-701. doi: 10.1002/jps.24396. Epub 2015 Feb 24. J Pharm Sci. 2015. PMID: 25711373 Review.
21 results