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

21. J. Catania, BioPharm Int. 24 (3), 20–24 (2011).

22. J. Catania, Biopharm Int. 24 (5), 20–24 (2011).

23. A. Sinclair and M. Monge, Bioprocess Int. 8 (3), 16–18 (2010).

24. T. Fuhr, State of QbD Implementation: Adoption, Successes, and Challenges (McKinsey 2010).

25. T. Fuhr and K. George, Pharmaceutical Manufacturing, 10 (3), 43–45 (2011).

26. T. Fuhr and K. George, "Moving Beyond the Business Case for QbD," March 13, 2011, http://www.pharmaqbd.com/mckinsey_beyond_business_case_qbd/, accessed Jul. 17, 2012.

27. P. Thomas, 2010, "QbD works: Detailing the Value Prop at Pfizer," http://www.pharmaqbd.com/?s=Qbd+works%3A+detailing+the+value+prop+at+pfizer, accessed Jul. 17, 2012.

28. B.K. Nunnally and J.S. McConnell, Six Sigma in the Pharmaceutical Industry (CRC Press, Boca Raton, FL, 2007) pp. 83–92.

29. B. Junker et al., PDA J. Pharm. Sci. Technol. 65 (3), 254–286 (2011).

30. "Woodcock Holds Court: Notes from a Lively CDER Town Hall," Pharma QbD, Jun. 21, 2010, http://www.pharmaqbd.com/woodcock_holds_court_town_hall/, accessed Jul. 17, 2012.

31. A. Shanley, Pharmaceutical Manufacturing 10 (2), 7 (2011).

32. FDA, Manual of Policies and Procedures, 5016.1: Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review, Feb. 28, 2011, http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM242665.pdf, accessed Jul. 17, 2012.

33. FDA, Guidance for Industry: Process Validation: General Prinicples and Practices (Rockville, MD, Jan. 2011).

34. D. Stevenson and T. Cochrane, Regulatory Rapporteur, 8 (3), 18–20 (2011).

35. J. Wechsler, BioPharm Int. 24 (7), 12–14 (2011).

36. J. Avellanet, Pharmaceutical Manufacturing, 10 (5), 10 (2011).

37. S.M. Paul et al., Nat. Rev. Drug. Discov. 9, 203–214 (2010).

38. N. Subbaraman, Nat. Biotechnol. 29 (5), 381 (2011).

39. J.A. DiMasi, and H.G. Grabowski, Managerial and Decision Economics 28, 469–479 (2007).


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