1. FDA, "Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach," (Rockville, MD, Aug. 2002).
2. K. Stryczek et al., "Capitalizing on Aggregate Data for Gaining Process Understanding-Effect of Raw Material, Environmental
and Process Conditions on the Dissolution Rate of a Sustained Release Product," J. Pharm. Innov.
2 (1–2), 6–17 (2007).
3. FDA, Draft Guidance for Industry, Process Validation: General Principles and Practices (Rockville, MD, November 2008).
4. ISA, ANSI/ISA S95.00.03, Enterprise-Control System Integration-Part 3: Activity Models for Manufacturing Operation Management
(Raleigh, NC, 2005).
5. J. Hirsch and T. Strother, "Lactose Particle Size Analysis Using FT-NIR Spectroscopy," Application Note 51557, Thermo
Fisher Scientific, Madison, WI (2007).
6. I. T. Cameron and F. Y. Wang, "Granulation Process Modeling," in the Handbook of Pharmaceutical Granulation Technology, D. M. Parikh, Ed. (Taylor & Francis, Boca Raton, FL, 2nd ed), pp. 555–590 (2005).
7. R. P. Cogdill et al., "The Financial Returns on Investment in Process Analytical Technology and Lean Manufacturing: Benchmarks
and Case Study," J. Pharm. Innov.
2 (1–2), 38–50 (2007).