No matter which comparability category we may use for a statistical comparison (with ρ = 0.05), a protocol should provide the design of experiments to be done and the pre-specified value for the allowable difference
in results. The prespecified maximum allowable difference is illustrated in CPMP's Points to Consider On The Choice Of Non-Inferiority
Margin.19 The allowable difference should be set similar to AMV or AMT. The difference should be set and justified by relating specifications
to SPC data and considering the likelihood of observing any of the four cases (1A, 1B, 2A, and 2B).13
Stephan O. Krause, PhD, is the manager of QC Technical Services and Compendial Liaison at Bayer HealthCare , LLC, Berkeley, CA 94701, tel. 510.705.4191, stephan.krause.b@bayer.com
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11. S.O. Krause, BioPharm Int. 17(11), 46–52 (2004).
12. S.O. Krause, BioPharm International Validation Guide, a supplement to BioPharm Int. 18(3) (2005).
13. S.O. Krause, BioPharm International Guide to Bioanalytical Advances, a supplement to BioPharm Int. 18(9) (2005).
14. S.O. Krause, BioPharm Int. 18(10), 52–59 (2005).
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(2004).
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http://www.emea.eu.int/pdfs/human/ich/036396en.pdf
18. Points to Consider on Switching Between Superiority and Non-Inferiority, CPMP (2000).
http://www.emea.eu.int/pdfs/human/ewp/048299en.pdf
19. Points to Consider On The Choice Of Non-Inferiority Margin, CPMP (2004). home.att.ne.jp/red/akihiro/emea/215899en_ptc.pdf
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