1. International Conference on Harmonization. Q6b, Specifications: Test procedures and acceptance criteria for biotechnological/biological
products. Geneva, Switzerland; 1999.
2. Swarbrick J, Boylan JC. Encyclopedia of pharmaceutical technology. New York: NetLibrary, Inc.; 2001.
3. Koren E, Zuckerman LA, Mire-Sluis AR. Immune response to therapeutic proteins in human—clinical significance, assessment
and prediction. Curr Pharm Biotechnol. 2002;3:349–360.
4. Graves DJ, Martin BL, Wang JH. Co- and post-translational modification of proteins. Chemical principles and biological
effects New York: Oxford University Press; 1994.
5. Apostol I, Kelner D. Managing the analytical lifecycle for biotechnology products: A journey from method development to
validation. BioProcess Int. 2008; in press.
6. Horwitz W, Albert R. A heuristic derivation of the Horwitz curve. Anal Chem. 1997;69: 789–790.
7. ASTM. Standard Practice for using significant digits in test data to determine conformance with specifications. In ASTM
Designation: E 29–04 ed. 2005; p 1–5.
8. Holme DM, Peck H. Analytical Biochemistry. 3rd ed. Upper Saddle River, New Jersey: Prentice-Hall, Inc.; 1998, p 9–19.
9. Agut C, Segalini A, Bauer M, Boccardi G. Relationship between HPLC precision and number of significant figures when reporting
impurities and when setting specifications, J Pharm Biomed Anal. 2006;41:442–448.
10. International Conference on Harmonization. Q2R1, Validation of analytical procedures. Geneva, Switzerland; 2005, p 1–13.
11. Ritter NM, Advant SJ, Hennessey J, Simmerman H, McEntire J, Mire-Sluis A, Joneckis C. What Is test method qualification?
Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess Int. 2004;2,32–46.