Equivalence studies for complex active ingredients and dosage forms

This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.     

Enhancing performance of protein and gene name recognizers with filtering and integration strategies

Named entity (NE) recognition is a fundamental task in biological relationship mining. This paper considers protein/gene collocates extracted from biological corpora as restrictions to enhance the precision rate of protein/gene name recognition. In addition, we integrate the results of multiple NE recognizers to improve the recall rates. Yapex and KeX, and ABGene and Idgene are taken as examples of protein and gene name recognizers, respectively. The precision of Yapex increases from 70.90 to 85.84% at the low expense of the recall rate (i.e., it only decreases 2.44%) when collocates are incorporated. When both filtering and integration strategies are employed together, the Yapex-based integration with KeX shows good performance, i.e., the F-score increases by 7.83% compared to the pure Yapex method. The results of gene recognition show the same tendency. The ABGene-based integration with Idgene shows a 10.18% F-score increase compared to the pure ABGene method. These successful methodologies can be easily extended to other name finders in biological documents.     

痧症简史

依据历代医学献,探讨痧症的演变历史。痧症最早见于晋代《肘后备急方》,指恙虫病。宋元时期,痧症包括艾灸后皮肤出现如砂样斑点的疾病、水伤寒、干霍乱、水沙等。明清以降,以痧命名的病症逐渐增至百种以上,涵盖内科、外科、妇科、儿科、五官科等,并出现了与伤寒、杂病混淆不清的状况。提示开展痧症病名的系统整理研究,最终规范痧症病名的使用,十分必要。     

医药行业域名争议与仲裁

互联网的发展使得域名的重要性和有限性日益彰显,从而不可避免的使域名成为企业抢注和争夺的对象。本文介绍了域名争议的仲裁机构以及医药行业在域名争议时,如何采用仲裁的办法来解决争端,以保护企业合法的权益。     

试从中医角度认识2019新型冠状病毒肺炎

2019新型冠状病毒肺炎属于中医疫病范畴,临床表现以发热、乏力、干咳为主,少数患者伴有鼻塞、流涕、腹泻等症状,其病位在肺,总的病机为湿郁于肺,治疗的关键环节是尽早正确及时除湿,通腑泄浊。依据四诊合参、审症求因,初步提出分期辨证论治:初期、中期、重症期、恢复期,在临证时需要个体化的中医治疗方案治疗本次疫病。未感染者要早预防,已感染者要早发现、早隔离、早诊断、早治疗。     

High sustained virologic response in genotypes 3 and 6 with generic NS5A inhibitor and sofosbuvir regimens in chronic HCV in myanmar

Exclusive HCV therapy clinical trials with genotype 6 patients in high prevalence areas have been sparse. We analysed the safety and efficacy of two generic, pangenotypic NS5A/NS5B combination oral DAA regimens, primarily in genotypes 3 and 6, in a real‐world setting: (a) daclatasvir/sofosbuvir (DCV/SOF) ± ribavirin (RBV) and (b) Velpatasvir/sofosbuvir (VEL/SOF ± RBV). Between December 2015 and November 2017, data from 522 patients were analysed, 311 of whom were treated with DCV/SOF ± RBV for 12/24 weeks (genotype 3: n = 193, genotype 6: n = 89) and 211 were treated with VEL/SOF ± RBV for 12/24 weeks (genotype 3: n = 83, genotype 6: n = 77). Overall SVR rates were high for both DCV/SOF ± RBV (96.1%, n = 299/311) and VEL/SOF ± RBV (95.3%, n = 201/211), and there was a good adverse event profile. Treatment naïve status and inclusion of RBV (in advanced fibrosis/cirrhosis) were significant independent predictors of achieving SVR12, while type of DAA regimen was not predictive. In this large cohort of genotypes 3 (n = 276) and 6 (n = 166; n = 127 unique subtype of 6c‐l), high SVR rates of 94.9% (n = 262/276) and 95.2% (n = 158/166), respectively, were noted. In conclusion, generic and pangenotypic DCV/SOF and VEL/SOF ± RBV regimens were highly effective and safe, in genotypes 3 and 6 chronic HCV in Myanmar. These efficacious pangenotypic regimens suggest that baseline genotype testing can be eliminated moving forward. While RBV may still be needed for those with advanced fibrosis/cirrhosis, in a global elimination strategy it would not be practical even if it does compromise SVR in a minority with difficult to treat characteristics.     

甘草的本草考证

甘草为我国传统常用大宗中药。本文通过系统梳理中国历代本草及医药典籍中甘草的记载,对甘草名称、原植物、产地、性状、质量评价、炮制方法、药性及功效主治进行考证。考证结果发现,甘草别名较多,尤以"国老"著称。其中,霝,大苦之称揭示汉代以前甘草品种混乱,自汉代以后才达到统一。原植物形态描述及图例考证认为,古本草记载甘草均为乌拉尔甘草,不包括《中国药典》记载正品甘草的另外2个种:光果甘草和胀果甘草。产地考证发现甘草核心产区已发生变迁,从以山西为主产区变迁为今天的以西北地区(宁夏、内蒙古、甘肃、新疆)为主要产区。性状特征及质量评价考证结果认为,从古至今甘草均以外皮细紧,紫红色外皮,断面有纹理,质坚实,富粉性为佳。炮制方法考证结果显示,其炮制方法经历了多样化的历史时期,随着应用实践,只有蜜炙法得以传承。药性及功效考证认为,本草中关于其药性的记载稍有不同,其功能主治古今基本一致。本文对历代典籍中记载的甘草进行考证,考证结果认为从古至今,甘草以乌拉尔甘草常用,主产地已发生变迁,蜜炙法是甘草唯一得到传承的炮制方法,其功效主治未发生较大变化,该研究结果为甘草的深入研究、资源开发、保护及利用提供本草学依据。     

关于生物仿制药药学研究问题的思考

由于生物制品的复杂性,化学仿制药物的研究方法并不完全适用于生物仿制药物。本文将就国内外对于生物仿制药注册申请的相关技术要求进行简要回顾,并从药品评价角度提出一些对于生物仿制药药学研究问题的个人观点和看法。