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 ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...