Evaluating manufacturing process profile comparability with multivariate equivalence testing: Case study of cell-culture small scale model transfer
Author:
Affiliation:
1. Sanofi Specialty Care Framingham Biologics; Framingham MA
2. Sanofi Specialty Care Biologics Quality; Westborough MA
Publisher
Wiley
Subject
Biotechnology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/btpr.2571/fullpdf
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3. A systematic approach for scale-down model development and characterization of commercial cell culture processes;Li;Biotechnol Prog.,2006
4. A multivariate test for population bioequivalence;Chervoneva;Stat Med.,2007
5. Bioequivalence trials, intersection-union tests and equivalence confidence sets;Berger;Stat Sci.,1996
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