During the development of biopharmaceuticals, high demands are placed on the quality of concentration data on which any decision to proceed to clinical trials will be based. Method validation (defining the acceptable limits within which data is deemed reliable) is a crucial part of the overall process through which a prospective drug passes. The results obtained during a validation process within the pharmaceutical industry for a concentration assay using Biacore C are presented. The quality of performance of the assay was sufficiently high to meet the GxP demands placed on drug companies by regulatory authorities.
The linearity of the standard curve, in addition to LOD and LOQ were statistically evaluated in the validation experiments. Assay specificity, accuracy, precision and robustness were also evaluated. (Data courtesy of Dr Ralph Abraham and Mary Quimby of Bristol-Myers Squibb Inc., Pharmaceutical Research Institute, Bioanalytical Sciences, Hopewell, New Jersey, USA)
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