The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. The words ‘method’ and ‘validation’ do not ...

Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in ...

Method validation is an essential part of establishing and ensuring the quality of analytical data. It cannot be guaranteed that data will be fit for purpose unless the performance of the test method ...

A simple, rapid, sensitive and accurate high-performance liquid chromatography method was developed and validated for the quantification of loratadine concentration in rabbit plasma using ...

Methods to determine the validity of regression models include comparison of model predictions and coefficients with theory, collection of new data to check model predictions, comparison of results ...