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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Detalhes bibliográficos
Publicado no:Biologics
Main Authors: Thennati, Rajamannar, Singh, Sanjay Kumar, Nage, Nitin, Patel, Yena, Bose, Sandip Kumar, Burade, Vinod, Ranbhor, Ranjit Sudhakar
Formato: Artigo
Idioma:Inglês
Publicado em: Dove Medical Press 2018
Assuntos:
Original Research
Acesso em linha: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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