Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and...

por Desai, Kalpna, Misra, Priya, Kher, Sanyukta, Shah, Nirmesh
Publicado 2018

Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for an Analytically Highly Similar Pegfilgrastim

por Desai, Kalpna, Catalano, Tina, Rai, Gurinder, Misra, Priya, Shah, Nirmesh
Publicado 2016

Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing

por Schoergenhofer, Christian, Schwameis, Michael, Firbas, Christa, Bartko, Johann, Derhaschnig, Ulla, Mader, Robert M, Plaßmann, Raute Sunder, Jilma-Stohlawetz, Petra, Desai, Kalpna, Misra, Priya, Jäger, Ulrich, Jilma, Bernd
Publicado 2018