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Clinical Confirmation to Demonstrate Similarity for a Biosimilar Pegfilgrastim: A 3-way Randomized Equivalence Study for a Proposed Biosimilar Pegfilgrastim Versus US-Licensed and EU-Approved Reference Producs in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

Experimental Hematology & Oncology, 2018
Kalpna Desai, Priya Misra, Sanyukta Kher and Nirmesh Shah

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A Demonstration of Analytical Similarity Comparing a Proposed Biosimilar Pegfilgrastim and Reference Pegfilgrastim

Biologicals, 2017
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd

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

Clinical Pharmacology in Drug Development, 2016
Kalpna Desai, Tina Catalano, Gurinder Rai, Priya Misra and Nirmesh Shah

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