Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed) - The author describes a methodology for developing a per product qualitative and semi-qualitative business case for a

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Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
The author describes a methodology for developing a per product qualitative and semi-qualitative business case for applying QbD to a biopharmaceutical product.


BioPharm International
Volume 25, Issue 8, pp. 40-47

REFERENCES

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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.

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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).


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