GLP‐compliant assay validation studies: considerations for implementation of regulations and audit of studies

@inproceedings{Li2006GLPcompliantAV,
  title={GLP‐compliant assay validation studies: considerations for implementation of regulations and audit of studies},
  author={Henry Li and Gillian Sharp and Connie Pilkington and Dominique Y. Pifat and Steve Petteway},
  year={2006}
}
Bioanalytical methods used in nonclinical safety studies are validated to demonstrate that the methods are reliable and reproducible for the intended use. Analytical method validation studies should be designed according to regulatory guidance on method validation. A cell-based assay is described to discuss fundamental validation parameters, such as repeatability, immediate precision, accuracy, and linearity. A Good Laboratory Practice (GLP) compliance program provides a useful platform for… CONTINUE READING

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