Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

An interview with Dr. Michael Dong, about his upcoming talk at Pittcon. Why are stability-indicating methods important in pharmaceutical analysis? The stability-indicating assay is perhaps the single ...

A simple, sensitive and selective method has been developed for quantification of Almotriptan (AL) in human plasma using Almotriptan-d(6) (ALD6) as an internal standard. Almotriptan and ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

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 ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories. An important operation in the registration ...

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 ...