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Page 1
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: reed ra. 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.
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: reed ra. 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.
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: reed ra. 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.
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: reed ra. 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 1: drug products administered by injection.
Baertschi SW, Clapham D, Foti C, Jansen PJ, Kristensen S, Reed RA, Templeton AC, Tønnesen HH. Baertschi SW, et al. Among authors: reed ra. J Pharm Sci. 2013 Nov;102(11):3888-99. doi: 10.1002/jps.23717. Epub 2013 Sep 5. J Pharm Sci. 2013. PMID: 24009146
38 results