In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...