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Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analyti

The Process Analytical Technology (PAT) initiative aims to move from a paradigm of ‘testing quality in’ to ‘building quality in by design’. It can be de

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initi

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequatel

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven a