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Leane M, Pitt K, Reynolds G; Manufacturing Classification System (MCS) Working Group.Leane M, et al.Pharm Dev Technol. 2015 Jan;20(1):12-21. doi: 10.3109/10837450.2014.954728. Epub 2014 Aug 27.Pharm Dev Technol. 2015.PMID: 25162770Review.