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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: raju gk. 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 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: raju gk. 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: raju gk. 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.
MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility.
Koenigsberg AL, Fowler V, Domike R, Brussel A, Barone PW, Keumurian FJ, Leung J, Wiebe ME, Brewer MT, Chan S, Dumey N, Fournillier A, Goodnight M, Kindermann J, Leavy R, Lee B, Minning S, Murphy M, Myers E, Nahabedian A, Nanda K, Parriott S, Raju GK, Scallan C, Schoch S, Shiminsky J, Shum B, Teitz S, Westrek B, Springs SL. Koenigsberg AL, et al. Among authors: raju gk. PDA J Pharm Sci Technol. 2023 Mar-Apr;77(2):115-132. doi: 10.5731/pdajpst.2021.012691. Epub 2022 Oct 14. PDA J Pharm Sci Technol. 2023. PMID: 36241212
15 results