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 ...

The pharmaceutical industry is starting to apply a Quality by Design (QbD) approach to the development of pharmaceutical products. It follows therefore, that the analytical procedures which are used ...

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 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 ...

Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...

Often, transferring an analytical method from R&D to quality control fails; success depends on determining where “the best” and “the most reliable” intersect. Analytical method transfer suffers from ...