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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.
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.
Many process and product failures can be traced to a poor understanding and control of crystallization processes. The Food and Drug Administration's process analytical technology (PAT) initiative is a collaborative effort with industry to introduce new and efficient …
Many process and product failures can be traced to a poor understanding and control of crystallization processes. The Food and Drug A …
45 results