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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.
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.
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu LX, Baker J, Berlam SC, Boam A, Brandreth EJ, Buhse L, Cosgrove T, Doleski D, Ensor L, Famulare J, Ganapathy M, Grampp G, Hussong D, Iser R, Johnston G, Kesisoglou F, Khan M, Kozlowski S, Lacana E, Lee SL, Miller S, Miksinski SP, Moore CM, Mullin T, Raju GK, Raw A, Rosencrance S, Rosolowsky M, Stinavage P, Thomas H, Wesdyk R, Windisch J, Vaithiyalingam S. Yu LX, et al. Among authors: iser r. 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.