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A clinical development plan was undertaken to identify rituximab s.c. doses achieving noninferior exposure to rituximab i.v., and to confirm PK\u2013clinical bridging, with the same efficacy and similar safety. This drew upon data from 1,579 patients with FL, CLL, or diffuse large B\u2010cell lymphoma in 5 clinical studies, and showed minimum steady\u2010state serum concentration (C<jats:sub>trough<\/jats:sub>) as the most appropriate exposure bridging measure. Population PK models were developed, simulations were run using covariates and PK parameters from clinical studies, and exposure\u2013efficacy and \u2013safety analyses performed. Population PKs showed a two\u2010compartment model with time\u2010dependent and \u2010independent clearances. Clearance and volume were predominantly influenced by body surface area; disposition and elimination were similar for the s.c. and i.v. formulations. 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