A Science and Risk Based Proposal for Understanding Scale and Equipment Dependencies of Small Molecule Drug Substance Manufacturing Processes
Author:
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1007/s12247-010-9083-1.pdf
Reference11 articles.
1. Watson TJN, Nosal R, am Ende D, Bronk K, Mustakis J, O’Connor G, et al. Journal of Pharmaceutical Innovation. 2007;2(3-4):71.
2. Lepore J, Spavins J. Journal of Pharmaceutical Innovation. 2008;3(2):79.
3. Caygill, Graham, Zanfir M, Gavriilidis A. Scalable reactor design for pharmaceuticals and fine chemicals production. 1: Potential scaleup obstacles. Org Process Res Dev. 2006;10:539–52.
4. Muller HL, Latimer JM. Anticipation of scale up issues in pharmaceutical development. Comput Chem Eng. 2008;33:1051–5. doi: 10.1016/j.compchemeng.2008.09.015 .
5. Bourne JR. Organic Process R&D. 2003;7:471–508.
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