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Page 1
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. 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. 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.
Stabilization of pharmaceuticals to oxidative degradation.
Waterman KC, Adami RC, Alsante KM, Hong J, Landis MS, Lombardo F, Roberts CJ. Waterman KC, et al. Among authors: alsante km. Pharm Dev Technol. 2002 Jan;7(1):1-32. doi: 10.1081/pdt-120002237. Pharm Dev Technol. 2002. PMID: 11852692 Review.
Hydrolysis in pharmaceutical formulations.
Waterman KC, Adami RC, Alsante KM, Antipas AS, Arenson DR, Carrier R, Hong J, Landis MS, Lombardo F, Shah JC, Shalaev E, Smith SW, Wang H. Waterman KC, et al. Among authors: alsante km. Pharm Dev Technol. 2002 May;7(2):113-46. doi: 10.1081/pdt-120003494. Pharm Dev Technol. 2002. PMID: 12066569 Review.
Identification of low-level degradants from low dose tablets.
Blanchard A, Lee C, Nickerson B, Lohr LL, Jensen AJ, Alsante KM, Sharp TR, Santafianos DP, Morris R, Snyder KD. Blanchard A, et al. Among authors: alsante km. J Pharm Biomed Anal. 2004 Oct 29;36(2):265-75. doi: 10.1016/j.jpba.2004.05.012. J Pharm Biomed Anal. 2004. PMID: 15496319