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 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 ...

Firms can use practical tools and criteria to implement advanced analytical test methods for biopharmaceuticals. They an also extend and maintain the validation status for a licensed test method from ...

The key statistical objective in IVD device evaluation is establishing performance criteria while minimizing bias and maximizing precision. While the statistical considerations and methodologies ...

Flow cytometry assay validation requires different analytical approaches in preclinical and clinical settings. A fit-for-purpose (FFP) strategy allows researchers to customize the validation to ...

The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...