Biomedical Engineering Reference
In-Depth Information
ACKNOWLEDGMENTS
The authors would like to thank Vincent Corvari and Mike DeFelippis for a useful
discussion onQbD approach and critical reading of the chapter, Bryan Harmon for useful
discussion on stability risk assessment, and Suntara Cahya for useful discussion on
statistical concepts of experimental design.
REFERENCES
[1] ICH Q8. Harmonised Tripartite Guideline Pharmaceutical Development, 2005.
[2] ICH Q9. Harmonised Tripartite Guideline Quality Risk Management, 2005.
[3] van Dijk MA, Vidarsson G. Monoclonal antibody-based pharmaceuticals. In: Crommelin
DJA, Sindelar RD, editors. Pharmaceutical Biotechnology. 2nd ed. London: Taylor & Francis;
2002. p 283-299.
[4] Tague NR. The Quality Toolbox. 2nd ed. Milwaukee: ASQ Quality Press; 2004. p 247.
