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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: foti c. 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 …
Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study.
Campbell JM, Foti C, Wang C, Adams N, Allain LR, Araujo G, Azevedo R, Franca JR, Hicks SR, Hostyn S, Jansen PJ, Kotoni D, Kuemmell A, Marden S, Rullo G, Santos ACO, Sluggett GW, Zelesky T, Baertschi SW. Campbell JM, et al. Among authors: foti c. J Pharm Sci. 2022 Feb;111(2):298-305. doi: 10.1016/j.xphs.2021.06.012. Epub 2021 Jun 7. J Pharm Sci. 2022. PMID: 34111446
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: foti c. 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 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: foti c. J Pharm Sci. 2013 Nov;102(11):3888-99. doi: 10.1002/jps.23717. Epub 2013 Sep 5. J Pharm Sci. 2013. PMID: 24009146
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: foti c. 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.
602 results