Examining Manufacturing Readiness for Breakthrough Drug Development

Earl Dye, Annie Sturgess,Gargi Maheshwari, Kimberly May,Colleen Ruegger, Usha Ramesh, Heow Tan, Keith Cockerill, John Groskoph,Emanuela Lacana,Sau Lee,Sarah Pope Miksinski

AAPS PharmSciTech(2015)

引用 8|浏览3
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关键词
breakthrough therapy,CMC,FDA
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