REFERENCES
- Buyse, M., Molenberghs, G., Burzykowski, T., Renard, D. and Geys, H. (2000), “The validation of surrogate endpoints in meta-analyses of randomized experiments”, Biostatistics, 1(1), 49-67.
- Buyse, M., Molenberghs, G. and Burzykowski, T. (2005), “The evaluation of surrogate endpoints (Vol. 427). T. Burzykowski (Ed.),” New York: Springer.
- Burzykowski, T. and Buyse, M. (2006). “Surrogate threshold effect: an alternative measure for meta‐analytic surrogate endpoint validation,” Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry, 5(3), 173-186.
- Buyse, M., Molenberghs, G., Paoletti, X., Oba, K., Alonso, A., Van der Elst, W., Burzykowski, T. (2016), “Statistical evaluation of surrogate endpoints with examples from cancer clinical trials,” Biom J, 58(1), 104–132.
- Clinical Review - Agalsidase beta (Fabrazyme), Genzyme Corp. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/agalgen042403r5.pdf
- Germain, D.P., Charrow, J., Desnick, R.J., et. al. (2015), “Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease,” J Med Genet, 52(5), 353–358.
- Molenberghs, G., Alonso, A.A., et al. (2014), “Statistical evaluation of surrogate endpoints in clinical studies. In: Young WR and Chen DG (eds),” Clinical trial biostatistics and biopharmaceutical applications. Boca Raton, FL: CRC Press.