REFERENCES
1. T. Fuhr, M. Holcomb, and P. Rutten, "Why Quality-by-Design Should be on the Executive Team's Agenda: Developing New Strategies
for New Times," in Outpacing Change in Pharma Operations, M. Losch, and U. Schrader, Eds. (McKinsey & Co., December, 2009) pp. 195–203.
2. B. Schmidt, "Implementing Quality by Design: Are you ready, or not?" Aug. 4, 2010,
http://www.pharmaqbd.com/schmidt_ready_for_qbd/, accessed Jul. 17, 2012.
3. H. Winkle, "Regulatory Modernization- FDA's Desired State for Product Quality," presentation at the BioProcess International
Conference (Providence, RI, Sept. 21, 2010).
4. H.N. Winkle and M.M. Nasr, Pharm. Tech. Eur.
23 (9), 10–19 (2011).
5. H.L. Levine, S.D. Jones, and A.D. Kanarek, Bioprocess Int.
9 (1), 64 (2011).
6. FDA, "Advancing Regulatory Science at FDA. A Strategic Plan," Aug. 2011, p. 14.
http://www.fda.gov/regulatoryscience, accessed Jul. 17, 2012.
7. T. Agres, Drug Disc. Devel.
14 (3), 10–11 (2011).
8. ICH Q8R2, Pharmaceutical Development, (August 2009).
9. J. Woodcock, "Pharmaceutical GMP's for the 21st Century: FDA's New Initiative on Drug Product Quality," Oct. 29, 2002,
http://www.fda.gov/ohrms/dockets/ac/02/slides/3902s1-11-Woodcock.ppt, accessed Jul. 17, 2012.
10. M. Welin, EU Regulatory Feedback, presentation at ISPE meeting (Brussels, Sept. 2010).
11. J.A.C. Lim et al., Bioprocess Int. 8 (10), 62–70 (2010).
12. B. Junker, BioPharm Int.
22 (5), 40–50 (2009).
13. C. Woelbeling, Pharmaceutical Engineering
28 (3), 36–48 (2008).
14. B. Chatterjee, Pharmaceutical Processing
26 (4), 8–9 (2011).
15. E. David, T. Tramontin, and R. Zemmel, Nat. Rev. Drug Disc.
8, 609–610 (2009).
16. E. David, T. Tramontin, and R. Zemmel, R., The Road to Positive R&D Returns,
http://www.mckinseyquarterly.com/Health_Care/Pharmaceuticals/The_road_to_positive_.../. 2010, accessed Jul. 17, 2012.
17. Z. Shahrokh, S. Price, and M. Voloch, BioPharm Int.
24 (8), 35–43 (2011).
18. S.D. Jones, and H.L. Levine, "Integrating Quality by Design into Early Process Development," presentation at IBC Preclinical
Scale Bioprocessing Conference (Boston, MA, Nov. 1–3, 2010).
19. Center for Chemical Process Safety, The Business Case for Process Safety, (American Institute of Chemical Engineers, 2nd Ed, 2010).
20. S. Martin-Moe et al., J. Pharm. Sci.
100 (8), 3031–3043 (2011).
|
