PAT Applied in Biopharmaceutical Process Development And Manufacturing

  • CRC Press
  • 2013
  • 0
  • English
  • 1
  • 9781439829462
0

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-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the comp