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Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe

Jobst Limberg1, Henrike Potthast

  • 1Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175, Bonn, Germany. Jobst.Limberg@bfarm.de

Biopharmaceutics & Drug Disposition
|April 16, 2013
PubMed

Keywords:
IVIVCbiopharmaceutic product characteristicsbiowaiverin vitro dissolutionquality controlregulatory status

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