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Analytical characterization of recombinant hCG and comparative studies with reference product
INTRODUCTION: Regulatory agencies recommend a stepwise approach for demonstrating biosimilarity between a proposed biosimilar and reference biological product emphasizing for functional and structural characterization to trace if there is any difference which may impact safety and efficacy. We studi...
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| Udgivet i: | Biologics |
|---|---|
| Main Authors: | , , , , , , |
| Format: | Artigo |
| Sprog: | Inglês |
| Udgivet: |
Dove Medical Press
2018
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| Fag: | |
| Online adgang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5796461/ https://ncbi.nlm.nih.gov/pubmed/29430170 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2147/BTT.S141203 |
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