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FDA/M-CERSI Co-Processed API Workshop Proceedings.
Schenck L, Patel P, Sood R, Bonaga L, Capella P, Dirat O, Erdemir D, Ferguson S, Gazziola C, Gorka LS, Graham L, Ho R, Hoag S, Hunde E, Kline B, Lee SL, Madurawe R, Marziano I, Merritt JM, Page S, Polli J, Ramanadham M, Sapru M, Stevens B, Watson T, Zhang H. Schenck L, et al. Among authors: polli j. J Pharm Sci. 2023 Aug;112(8):2069-2078. doi: 10.1016/j.xphs.2023.01.006. Epub 2023 Jan 10. J Pharm Sci. 2023. PMID: 36638959
Understanding pharmaceutical quality by design.
Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Yu LX, et al. Among authors: polli j. AAPS J. 2014 Jul;16(4):771-83. doi: 10.1208/s12248-014-9598-3. Epub 2014 May 23. AAPS J. 2014. PMID: 24854893 Free PMC article. Review.
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: polli j. 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.
310 results