Evaluating the Bioequivalence of Antibody–Drug Conjugates - Pharmaceutical Technology

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Evaluating the Bioequivalence of Antibody–Drug Conjugates
The authors discuss the analytical methods and related testing for bioequivalence studies of ADCs. This article is part of a special issue on analytical technology.


Pharmaceutical Technology
pp. s22-s27

References

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3. Genentech, "Herceptin (trastuzumab) Intravenous Infusion, Full Prescribing Information" (South San Francisco, CA), http://www.gene.com/gene/products/information/oncology/herceptin/, accessed Oct. 10, 2011.

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8. FDA, "FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market," Press Release (Rockville, MD, June 21, 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm, accessed Oct. 10, 2011.

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11. A. Beck, T. Wurch, J.M. Reichert, Landes Biosci. 3 (2), 111–132 (2011).

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13. FDA, "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" (Rockville, MD, Feb. 1997).

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