EPISODE · Jul 25, 2023 · 22 MIN
The Regulatory Pathway to Biosimilar Approval
from GHAPPcast
Welcome to our third episode of the GHAPP & RhAPP biosimilar podcast series! In this episode host Amanda Mixon, PA-C has an in-depth conversation with the incredible Danielle Gatti-Palumbo, PharmD, BCACP, AAHIVP, about The Regulatory Pathway to Biosimilar Approval.The learning objectives and goals for this episode are to:-Summarize the totality of evidence approach to determining biosimilarity including: -Analytical testing for comparative structural and functional characterization -Nonclinical testing to evaluate the safety profile -Comparative human pharmacokinetic and pharmacodynamic studies -Immunogenicity Assessment -Comparative clinical studies if neededPlease take our evaluation regarding this podcast here: https://www.ghapp.org/biosimilars-podcast-eval
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Welcome to our third episode of the GHAPP & RhAPP biosimilar podcast series! In this episode host Amanda Mixon, PA-C has an in-depth conversation with the incredible Danielle Gatti-Palumbo, PharmD, BCACP, AAHIVP, about The Regulatory Pathway to Biosimilar Approval.The learning objectives and goals for this episode are to:-Summarize the totality of evidence approach to determining biosimilarity including: -Analytical testing for comparative structural and function...
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The Regulatory Pathway to Biosimilar Approval
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