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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
AAPS J. 2015 Jul;17(4):1011-8. doi: 10.1208/s12248-015-9754-4. Epub 2015 Apr 4.
AAPS J. 2015.
PMID: 25840884
Free PMC article.
Advancing Product Quality: a Summary of the Second FDA/PQRI Conference.
Yu LX, Akseli I, Allen B, Amidon G, Bizjak TG, Boam A, Caulk M, Doleski D, Famulare J, Fisher AC, Furness S, Hasselbalch B, Havel H, Hoag SW, Iser R, Johnson BD, Ju R, Katz P, Lacana E, Lee SL, Lostritto R, McNally G, Mehta M, Mohan G, Nasr M, Nosal R, Oates M, O'Connor T, Polli J, Raju GK, Ramanadham M, Randazzo G, Rosencrance S, Schwendeman A, Selen A, Seo P, Shah V, Sood R, Thien MP, Tong T, Trout BL, Tyner K, Vaithiyalingam S, VanTrieste M, Walsh F, Wesdyk R, Woodcock J, Wu G, Wu L, Yu L, Zezza D.
Yu LX, et al. Among authors: iser r.
AAPS J. 2016 Mar;18(2):528-43. doi: 10.1208/s12248-016-9874-5. Epub 2016 Feb 9.
AAPS J. 2016.
PMID: 26860627
Free PMC article.
No abstract available.
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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: iser r.
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.
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