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Global regulatory standards for the approval of biosimilars.
Mounho B, Phillips A, Holcombe K, Grampp G, Lubiniecki T, Mollerup I, Jones C. Mounho B, et al. Among authors: lubiniecki t. Food Drug Law J. 2010;65(4):819-37, ii-iii. Food Drug Law J. 2010. PMID: 24479248
Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy.
Narhi LO, Corvari V, Ripple DC, Afonina N, Cecchini I, Defelippis MR, Garidel P, Herre A, Koulov AV, Lubiniecki T, Mahler HC, Mangiagalli P, Nesta D, Perez-Ramirez B, Polozova A, Rossi M, Schmidt R, Simler R, Singh S, Spitznagel TM, Weiskopf A, Wuchner K. Narhi LO, et al. Among authors: lubiniecki t. J Pharm Sci. 2015 Jun;104(6):1899-1908. doi: 10.1002/jps.24437. Epub 2015 Apr 1. J Pharm Sci. 2015. PMID: 25832583 Review.
Subvisible (2-100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis.
Corvari V, Narhi LO, Spitznagel TM, Afonina N, Cao S, Cash P, Cecchini I, DeFelippis MR, Garidel P, Herre A, Koulov AV, Lubiniecki T, Mahler HC, Mangiagalli P, Nesta D, Perez-Ramirez B, Polozova A, Rossi M, Schmidt R, Simler R, Singh S, Weiskopf A, Wuchner K. Corvari V, et al. Among authors: lubiniecki t. Biologicals. 2015 Nov;43(6):457-73. doi: 10.1016/j.biologicals.2015.07.011. Epub 2015 Aug 29. Biologicals. 2015. PMID: 26324466 Review.