Application of an improved procedure for testing the linearity of analytical methods to pharmaceutical analysis.
Examination of the requirements of the Food and Drug Administration (FDA) for evaluating the linearity of an analytical method reveals them to be unsatisfactory, in both the definition of linearity and in the specifications for testing this property of an analytical method. A new definition for linearity is proposed, along with a new method for evaluating this property of an analytical method, one that is consistent with the definition. The method is tested by re-evaluating the linearity of data collected from a Near-Infrared method of analysis of pharmaceutical preparations.
Mark
Howard
H
Mark Electronics, 21 Terrace Avenue, Suffern, NY 10901, USA. hlmark@prodigy.net
D000465:Algorithms; D001185:Artificial Intelligence; D002138:Calibration; D002214:Capsules; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D002851:Chromatography, High Pressure Liquid; D005103:Expert Systems; D016014:Linear Models; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared; D013607:Tablets
D002214:Capsules; D004364:Pharmaceutical Preparations; D013607:Tablets