Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative.
Hinz
Dirk C
DC
Process Control Department, Schering AG, Global CMC Development, 13342 Berlin, Germany. dirk.hinz@schering.de
D002623:Chemistry Techniques, Analytical; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*