Gauge repeatability and reproducibility for accessing variability during dissolution testing: a technical note.
Gao
Zongming
Z
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, MO 63101, USA. Zongming.Gao@fda.hhs.gov
Moore
Terry
T
Smith
Anjanette P
AP
Doub
William
W
Westenberger
Benjamin
B
Buhse
Lucinda
L
D002138:Calibration; D008956:Models, Chemical; D015588:Observer Variation; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011241:Prednisone / Q000737:chemistry; D011786:Quality Control; D015203:Reproducibility of Results; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D013997:Time Factors
D004364:Pharmaceutical Preparations; D013607:Tablets; D011241:Prednisone