A Novel Bootstrapping Test for Analytical Biosimilarity - The AAPS Journal
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| A Novel Bootstrapping Test for Analytical Biosimilarity - The AAPS Journal |
| Showing analytical similarity is key to license biosimilar products with reduced or circumvented clinical effort. Statistical procedures to assess analytical similarity of quality attributes at drug product level have been highly debated by academia, industry, and regulatory agencies. In the past, a tiered approach was recommended by regulators, consisting of equivalence tests and quality range tests. |
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Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Sarasota FL
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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