Applicability of statistical reliability methods to the validation process.
This paper discusses some statistical considerations for the reliability of validation processes. An underlying theme is assessment of sources of variability for validation data. Confidence intervals and other statistical methods can clarify the impact of such variability. Statistical strategies for strengthening the design of systems for evaluation of validation processes are outlined.
Koch
G G
GG
Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill 27599-7400.
D001688:Biological Products / Q000592:standards*; D001699:Biometry; D015203:Reproducibility of Results; D012449:Safety
D001688:Biological Products