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

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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).

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


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