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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: thien mp. 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.
How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation.
McGoldrick M, Gastineau T, Wilkinson D, Campa C, De Clercq N, Mallia-Milanes A, Germay O, Krishnan J, Van Ooij M, Thien MP, Mlynarczyk PJ, Saltus E, Wauters F, Juvin P, Clenet D, Basso A, Dellepiane N, Pagliusi S, Collaço de Moraes Stávale M, Sivaramakrishnan VH, Desai S. McGoldrick M, et al. Among authors: thien mp. Vaccine. 2022 Feb 23;40(9):1223-1230. doi: 10.1016/j.vaccine.2021.12.038. Vaccine. 2022. PMID: 35180994 Free PMC article. Review.
How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation.
McGoldrick M, Gastineau T, Wilkinson D, Campa C, Clercq N, Mallia-Milanes A, Germay O, Krishnan J, Van Ooij M, Thien MP, Mlynarczyk PJ, Saltus E, Juvin P, Clenet D, Basso A, Dellepiane N, Pagliusi S, de Moraes Stávale MC, Sivaramakrishnan VH, Desai S. McGoldrick M, et al. Among authors: thien mp. Vaccine. 2022 Feb 23;40(9):1215-1222. doi: 10.1016/j.vaccine.2021.11.098. Vaccine. 2022. PMID: 35180993 Free PMC article. Review.