Kimberly Vukovinsky

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Recent concerns about the applicability of design space boundaries developed on small scale to commercial manufacturing processes have been raised by regulators worldwide. These concerns center around the scalability of unit operations and their corresponding process parameters, and the impact this has on the desired attributes of the drug substance or(More)
  • Michael Glodek, Stephen Liebowitz, Bristol-Myers Squibb, Randal Mccarthy, Schering Plough, Grace Mcnally +13 others
  • 2006
The Product Quality Research Institute (PQRI) is collaborative effort between the pharmaceutical industry, regulatory agencies, and academia. One of the purposes of PQRI is to promote discussion on current topics of interest in the pharmaceutical field. To that end, PQRI commissioned a working group to develop a White Paper that discusses the concept of(More)
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