QbD:Regulatory and Scientific Possibilities and Challenges

Niamh Madigan

Gert Ragnarsson, Director of the Swedish Medical Projects Agency, discusses the biggest milestones in QbD over the last decade, including: The establishment of harmonised guidelines The Formation of the EMA The recent document published by the FDA, which is a significant step in dealing with advanced formulations   He also looks to the future growth of generics and the effects QbD and PAT will have on that market. Have Your Sa...
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