{"title":"高阶结构测定在生物药品使用稳定性研究中的重要性","authors":"A. Astier","doi":"10.5639/gabij.2020.0902.009","DOIUrl":null,"url":null,"abstract":"Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"8 1","pages":""},"PeriodicalIF":0.3000,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals\",\"authors\":\"A. Astier\",\"doi\":\"10.5639/gabij.2020.0902.009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used.\",\"PeriodicalId\":43994,\"journal\":{\"name\":\"GaBI Journal-Generics and Biosimilars Initiative Journal\",\"volume\":\"8 1\",\"pages\":\"\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2020-06-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"GaBI Journal-Generics and Biosimilars Initiative Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5639/gabij.2020.0902.009\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"GaBI Journal-Generics and Biosimilars Initiative Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5639/gabij.2020.0902.009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals
Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used.
期刊介绍：
The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.
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