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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: raw a. 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.
Applications of process analytical technology to crystallization processes.
Yu LX, Lionberger RA, Raw AS, D'Costa R, Wu H, Hussain AS. Yu LX, et al. Among authors: raw as. Adv Drug Deliv Rev. 2004 Feb 23;56(3):349-69. doi: 10.1016/j.addr.2003.10.012. Adv Drug Deliv Rev. 2004. PMID: 14962586 Review.
The Food and Drug Administration's process analytical technology (PAT) initiative is a collaborative effort with industry to introduce new and efficient manufacturing technologies into the pharmaceutical industry. ...This review introduces the concept of PAT and discusses …
The Food and Drug Administration's process analytical technology (PAT) initiative is a collaborative effort with industry to introduc …
Quality by design: concepts for ANDAs.
Lionberger RA, Lee SL, Lee L, Raw A, Yu LX. Lionberger RA, et al. Among authors: raw a. AAPS J. 2008 Jun;10(2):268-76. doi: 10.1208/s12248-008-9026-7. Epub 2008 May 9. AAPS J. 2008. PMID: 18465252 Free PMC article.
41 results