Perspectives on Method Validation: Importance of Adequate Method Validation

The appropriate validation of analytical methods has become an essential part of successful drug development and characterization. Validation of a method involves using experimental design to prove that the method can produce accurate and precise results within the scope of its intended use. Understanding the application and limitations of the test method will allow for accurate assessment of sample information, ranging from process outputs to commercial release testing and many steps in between. If the method validation has not been performed or has been performed in an inadequate manner, the method is not proven to provide reliable data.