Search results for "In Biosimilar Development Nonclinical Considerations"
This guidance is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar. 2
1 2 WHO/BS/2016.2290 3 ENGLISH ONLY 4 5 Guidelines on evaluation of monoclonal antibodies as 6 similar biotherapeutic products (SBPs) 7 8 NOTE: 9 This document has been prepared for the purpose of inviting comments and suggestions on the 10 proposals contained therein, which will then be considered by the Expert …
The immunogenicity of therapeutic proteins- what you don’t know can hurt YOU and the patient João A. Pedras -Vasconcelos, PhD CMC and Immunogenicity Reviewer
Michael W. Leach Regulatory and Scientific Challenges in Biosimilar Development: Nonclinical Considerations Drug Safety R&D, Andover, MA 978.247.1023
HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use. INFLECTRA safely and effectively. See full prescribing information for INFLECTRA.
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