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TITLE: How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider
AUTHORS: Huub Schellekens; Sven Stegemann; Vera Weinstein; Jon S B de Vlieger; Beat Fluehmann; Stefan Muehlebach; Rogerio Gaspar; Vinod P Shah; Daan J A Crommelin;
PUBLISHED: 2014, SOURCE: AAPS JOURNAL, VOLUME: 16, ISSUE: 1
INDEXED IN: Scopus WOS CrossRef
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TITLE: Scientific considerations for complex drugs in light of established and emerging regulatory guidance. Scientific considerations for complex drugs  Full Text
AUTHORS: Chris Holloway; Jan Mueller Berghaus; Beatriz Silva Lima ; Sau (Larry) Lee; Janet S Wyatt; Michael M Nicholas; Daan J A Crommelin;
PUBLISHED: 2012, SOURCE: ANNALS MEETING REPORTS 2013, VOLUME: 1276, ISSUE: 1
INDEXED IN: Scopus WOS CrossRef