The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

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 ...

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 ...

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 ...