Special column on the quality analysis of recombinant hormone drugs

Considerations on research of national standards for recombinant hormones*

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  • Division of Hormone, National Institutes for Food and Drug Control, Beijing 102629, China

Received date: 2021-08-16

  Online published: 2024-06-21

Abstract

Recombinant hormones drugs are pioneers among therapeutic biotechnology products for clinical use, and their total global sales volume are the second class of recombinant protein drugs next to monoclonal antibodies. Such drugs usually have “counterarts” of listed natural drugs extracted from tissues,with mature studies on the correlations between their structures and functions and clear efficacy. It plays an irreplaceable role in the treatment of various chronic diseases and degenerative diseases. The technical points, issues and solutions, the basis of the research and the evaluation of the results which were generally followed and paid attention to in the process of the standard study of the pharmacopoeia of recombinant hormones drugs were discussed. Some research strategies for future activities on national standard drafting of recombinant hormones were also prospected and discussed.

Cite this article

LIANG Cheng-gang, LI Jing, ZHANG Hui, LÜ Ping, LI Zhan-jun . Considerations on research of national standards for recombinant hormones*[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(1) : 3 -12 . DOI: 10.16155/j.0254-1793.2022.01.01

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