Process development in an era of risk-based regulatory perspective

ORGN 183

Simon Leung, simon.leung@bms.com1, Ehrlic Lo1, Mourad Hamedi, mourad.hamedi@bms.com2, Eric Dowdy, Daniel Watson, and Ariel Hou. (1) Process R&D Department, Bristol-Myers Squibb Pharmaceutical Research Institute, One Squibb Drive, New Brunswick, NJ 08903, (2) Process Research and Development, Bristol-Myers Squibb Company, Pharmaceutical Research Institute, One Squibb Drive, New Brunswick, NJ 08903
One of the key elements of the risk-based approach espoused by the FDA's cGMP initiative for the 21st century is the minimization of risk associated with manufacturing processes based upon the development of thorough understanding and enhanced control during research and development. In this presentation, two examples will be used to illustrate how modern research tools are being leveraged to achieve faster development and optimization, and the achievement of reproducible control over chemical processes.
 

The Role of Organic Synthesis in Early Clinical Drug Development
8:30 AM-12:00 PM, Monday, 27 March 2006 Georgia World Congress Center -- C303/304/305, Oral

Division of Organic Chemistry

The 231st ACS National Meeting, Atlanta, GA, March 26-30, 2006