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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: baertschi sw. 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.
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.
Alsante KM, Huynh-Ba KC, Baertschi SW, Reed RA, Landis MS, Furness S, Olsen B, Mowery M, Russo K, Iser R, Stephenson GA, Jansen P. Alsante KM, et al. Among authors: baertschi sw. AAPS PharmSciTech. 2014 Feb;15(1):237-51. doi: 10.1208/s12249-013-0061-z. Epub 2013 Dec 21. AAPS PharmSciTech. 2014. PMID: 24363207 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. 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.
Although essential guidance to cover the photostability testing of pharmaceuticals for manufacturing and storage is well-established, there continues to be a significant gap in guidance regarding testing to support the effective administration of photosensitive drug products. Con …
Although essential guidance to cover the photostability testing of pharmaceuticals for manufacturing and storage is well-established, there …
Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products.
Allain L, Baertschi SW, Clapham D, Foti C, Lantaff WM, Reed RA, Templeton AC, Tønnesen HH. Allain L, et al. Among authors: baertschi sw. J Pharm Sci. 2016 May;105(5):1586-1594. doi: 10.1016/j.xphs.2016.02.035. Epub 2016 Apr 5. J Pharm Sci. 2016. PMID: 27056630 Review.
41 results