Pharma Discusses FDA Suggestion on Quality by Design

Mr. KK Bhagchandani, Director of Sales, Asia-Pacific Operations, ACD/Labs, participated in a panel discussion at the DIA IT Life Sciences Summit 2012 about the US FDA's recent announcement asking for generic drug manufactorers to implement Quality by Design (QbD) into their abbreiviated new drug applications by 2013.

Mr. Bhagchandani states, "QbD is all about systematically designing methods which are robust. Variables in an experiment such as chromatography column, mobile phase, etc., need to be designed accordingly. A mathematical approach can be adopted to design a strategy for multivariate analysis, where more than one dynamic entity is at play."

Read the full article online at BioSpectrum.