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CURRENT SCIENCE, VOL. 114, NO. 12, 25 JUNE 2018 2518 *For correspondence. (e-mail: rashed@ukm.edu.my) 12. Boross, P. and Leusen, J. H. W., Mechanisms of action of CD20 antibodies. Am. J. Cancer. Res., 2012, 2(6), 676–690. 13. Harjunpaa, A., Junnikkala, S. and Meri, S., Rituximab (antiCD20) therapy of B-cell lymphomas: direct complement killing is superior to cellular effector mechanisms. Scand. J. Immunol., 2000, 51, 634–641. 14. USP/MC; Rituximab Summary Validation Report, Report, USP Medicines Compendium, 2013. 15. Reed, G. F., Lynn, F. and Meade, B. D., Use of coefficient of variation in assessing variability of quantitative assays. Clin. Diagn. Lab. Immunol., 2002, 9(6), 1235–1239. 16. Biological Assay Validation. United States Pharmacopoeia, 35– NF 30, 2012. 17. Dafale, N., Semwal, U., Agarwal, P., Sharma, P. and Singh, G., Development and validation of microbial bioassay for quantification of levofloxacin in pharmaceutical preparations. J. Pharm. Anal., 2015, 5(1), 18–26. 18. Coffey, T, Grevenkamp, M., Wilson, A. and Hu, M., Biological assay qualification using design of experiments. Bioprocess. Int., 2013, 11(6), 42–49. 19. Tsiftsoglou, A. S., Ruiz. S. and Schneider, C. K., Development and regulation of biosimilars: current status and future challenges. BioDrugs., 2013, 27(3), 203–211. 20. ICH harmonised tripartite guideline, ‘Validation on analytical procedures: text and (methodology)’, International Council for Harmonisation, Q2 (R1), Step 4, 2005. 21. Design and development of biological assays, United States Pharmacopoeia, 35–NF 30, 2012.

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