1. FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products (April 1996).
2. ICH Guidance for Industry: Q5E Comparability of Biotechnology/Biological Product Subject to Changes in Their Manufacturing Process (June 2005).
3. Chatfield, M.J., Borman, P.J.; Damjanov, I.; “Evaluating Change During Pharmaceutical Product Development and Manufacture – Comparability and Equivalence”; Quality and Reliability Engineering International; 27 (2011), pp 629–640.
4. Howe, W.G.; Two-Sided Limits for Normal Populations – Some Improvements; Journal of the American Statistical Association, 64 (1969), pp. 610–620.
5. Hahn, G.J. and Meeker, W.Q.; Statistical Intervals A Guide for Practioners; John Wiley & Sons, Inc.; (1991).