REFERENCES
1. US Food and Drug Administration (FDA). Guidance for Industry. Q8, Pharmaceutical Development. Rockville, MD; 2006 May.
2. US FDA. PAT Guidance for Industry—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.
Rockville, MD; 2004 Sept.
3. US FDA. Guidance for Industry. Q9 Quality Risk Management. Rockville, MD; 2006 June.
4. Nail SL, Searles JA. Elements of quality by design in development and scale-up of freeze-dried parenterals. BioPharm Int.
2008 Jan;21(1):44-52.
5. Cook S, Patton KA, Bazemore LR. Quality by design in the CMO environment. BioPharm Int. 2007 Dec;20(12):28-37.
6. Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: case study of Pichia pastoris
fermentation. Biotechnol Prog. 2008;24:655-662.
7. Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Intl. 2007 April;20(5):36-40.
8. Seely J. Process Characterization. In: Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals.
Boca Raton, FL: Taylor & Francis; 2005. p. 31-68.
9. Seely RJ, Haury J. Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes. In Rathore
AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005. p.
13-30.
|