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Development and validation of a ligand-binding assay for quantification of the F(ab')(2) antivenom of Daboia russelii siamensis in human serum and its application to a phase I clinical study

文献类型：期刊论文

作者Gui, Yuzhou2,3; Yu, Chengyin1,2,3; Zhou, Jiaye2,3; Xin, Liang2,3; Chen, Ze4; Fan, Tiejiong4; Lu, Shuang4; Jia, Jingying2,3; Liu, Gangyi2,3
刊名JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
出版日期2022-04-01
卷号212页码:8
关键词F(ab')(2) antivenom Daboia russelii siamensis Ligand-binding assay Method validation Clinical trial
ISSN号0731-7085
DOI10.1016/j.jpba.2022.114645
通讯作者Liu, Gangyi(gyliu@shxh-centerlab.com)
英文摘要Daboia russelii siamensis accounts for most of snakebite mortalities in China, yet, specific treatment against the venom toxins is absent in clinical practice. The F(ab')(2) antivenom of Daboia russelii siamensis is manufactured and approved for the clinical trial in China. To satisfy the need for clinical pharmacokinetic research, this study aimed to develop a ligand binding assay (LBA) for the quantification of F(ab')(2) antivenom of Daboia russelii siamensis in human serum. A diverse combination of conditions was optimized based on the fitness of the calibration curve and selectivity. The established LBA undergoes thorough method validation according to the guidelines of regulatory authorities. In the calibration range 1.0-64 mu g/mL, the correlation coefficient r(2) was from 0.9970 to 1.000, indicating good fitness. Accuracy and precision were within +/- 20%. Dilution linearity was observed in the ultra-high quality-control (QC) samples (500 mu g/mL). In addition, the assay was free from hook effect, the endogenous interferences and exogenous interferences. The QC samples were stable under different handling and storage conditions. The validated assay was successfully applied to a phase I clinical study of the F (ab')(2) antivenom of Daboia russelii siamensis in Chinese healthy volunteers. The peak concentrations exhibited dose-proportionality. In conclusion, this study provides a novel and reliable LBA method for the clinical pharmacokinetic research of F(ab')(2) antivenom of Daboia russelii siamensis. It will facilitate further clinical trials in treating the snakebite of Daboia russelii siamensis.
WOS关键词MONOCLONAL-ANTIBODY ; PHARMACOKINETICS ; F(AB')(2) ; POTENCY ; SAFETY ; ELISA
资助项目National Natural Science Foundation of China[81903601] ; Shanghai Sailing Program[19YF1444900]
WOS研究方向Chemistry ; Pharmacology & Pharmacy
语种英语
WOS记录号WOS:000763593000005
出版者ELSEVIER
源URL[http://119.78.100.183/handle/2S10ELR8/300239]  
专题中国科学院上海药物研究所
通讯作者Liu, Gangyi
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, 555 Zuchongzhi Rd, Shanghai 201203, Peoples R China
2.Fudan Univ, Xuhui Hosp, Shanghai Xuhui Cent Hosp Zhongshan, Shanghai 200031, Peoples R China
3.Shanghai Engn Res Ctr Phase I Clin Res & Qual Con, Shanghai 200031, Peoples R China
4.Shanghai Serum Biotechnol Co Ltd, Shanghai 201707, Peoples R China
推荐引用方式
GB/T 7714		 Gui, Yuzhou,Yu, Chengyin,Zhou, Jiaye,et al. Development and validation of a ligand-binding assay for quantification of the F(ab')(2) antivenom of Daboia russelii siamensis in human serum and its application to a phase I clinical study[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2022,212:8.
APA Gui, Yuzhou.,Yu, Chengyin.,Zhou, Jiaye.,Xin, Liang.,Chen, Ze.,...&Liu, Gangyi.(2022).Development and validation of a ligand-binding assay for quantification of the F(ab')(2) antivenom of Daboia russelii siamensis in human serum and its application to a phase I clinical study.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,212,8.
MLA Gui, Yuzhou,et al."Development and validation of a ligand-binding assay for quantification of the F(ab')(2) antivenom of Daboia russelii siamensis in human serum and its application to a phase I clinical study".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 212(2022):8.

入库方式： OAI收割

来源：上海药物研究所

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