Perspectives on process systems engineering R&D in support of pharmaceutical product/process development and manufacturing

Computer Aided Chemical Engineering

Volumn 24, Issue , 2007, Pages 35-38

  V Rex Reklaitis, Gintaras ^a  

^a PURDUE UNIVERSITY   (United States)

Author keywords

enterprise wide decision making and information model management.; Process and product design; process operations and management

Indexed keywords

EID: 40849083855     PISSN: 15707946     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S1570-7946(07)80029-0     Document Type: Article

References (6)

1. March. FDA. Challenge and Opportunity on the Critical Path to New Medical Products (2004). http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
2. FDA. PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Guidance for Industry (2004). http://www.fda.gov/cder/guidance/6419fnl.pdf
3. FDA. Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach Final Report Fall (2004). http://fda.gov/cder/gmp/gmp2004/GMP_fmalreport2004.html
4. National Institute for Pharmaceutical Technology and Education, www.nipte.org
5. Zhao, Jain C.-H.A., Hailemariam L., Suresh P., Akkisetti P., Joglekar G., Venkatasubramanian V., Reklaitis G.V., Morris K., and Basu P. Journal of Pharm. Innovation Vol 1 No. 1 (2006) 23-36
6. (in press). Varma V.A., Blau G.E., Pekny J.F., and Reklaitis G.V. Computers & Chem Engr 31 (2007)