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Xihua Scientific


Bioanalytical Services

Over 400 methods for generic drugs 

MD/MV & sample analysis for BE studies and FIH studies with quick turn-around time 

PK & BE statistics analysis

> 95% method using stable isotope labeled internal standard

Over 100 domestic clients.

Partnership with tier-1 hospitals, clinical CRO 

around the country

MD/MV for LM drug PK, ADA, and Nab assays and biomarkers

Reagent production & labelling

Sample analysis for clinical trials for biosimilars and innovative drugs

Method developed for 20 popular biosimilars

PK statistics analysis


Clinical Services

JV with Li-Ou Clinical Services Inc. Ltd.

1 dedicated site for Xihua

Partnership with 8 clinical CROs and over 20 clinical sites

BE pilot and pivotal studies

FIH trial for innovative drugs

PK and BE statistics analysis


Consulting Services

Training classes on regulated bioanalysis in collaboration with CFDA

For scientist: Regulation, instrument & LIMS operation, documentation

For QA & management: study management, inspection, deviation reporting and remediation 

Training offered by Xihua senior management

Classes approved & certificate issued by CFDA

Fit-for-purpose training at client’s site

On-site inspection on bioanalytical and clinical studies before regulatory agency audit

Domestic mainland studies

India/US/Canada/Taiwan studies

On-site consultation for formulation commercial production


产品名称: 生物分析
型号:
时间: 2017 - 06 - 02
Xihua ScientificBioanalytical ServicesOver 400 methods for generic drugs MD/MV & sample analysis for BE studies and FIH studies with quick turn-around time PK & BE statistics analysis 95% method using stable isotope labeled internal standardOver 100 domestic clients.Partnership with tier-1 hospitals, clinical CRO around the countryMD/MV for LM drug PK, ADA, and Nab assays and biomarkersReagent production & labellingSample analysis for clinical trials for biosimilars an...
产品名称: 临床试验
型号:
时间: 2019 - 03 - 14
Clinical protocol designs, phase I and BE trials, PK analysis.临床设计咨询:依据化学仿制药的变异及中西方药监机构要求,提供临床预试验及正式试验设计咨询,并根据预试验结果提供决策及正式试验设计方案临床资源管理:帮助申办方在台湾及印度协调临床资源,开展预BE试验。
产品名称: 咨询服务
型号:
时间: 2019 - 03 - 14
Training on BA regulation and quality management in collaboration with CFDA, inspections on clinical trials and bioanalysis临床设计咨询:依据化学仿制药的变异及中西方药监机构要求,提供临床预试验及正式试验设计咨询,并根据预试验结果提供决策及正式试验设计方案。生物分析技术及质量体系培训:熙华检测志愿与国内同行分享多年执行中西方行业规范的经验,为提高中国生物分析行业的整体质量水平做出应有的贡献。熙华检测与熙神医药共同举办生物分析技术及质量体系培训。培训分技术和质量体系两个方面,面向有志于从事生物分析行业的科研人员、机构管理及质量管理人员、药企项目核查人员、政府稽查专家。熙华检测提供专门的培训场所(安徽滁州),学员可以亲自操作仪器设备及使用LIMS系统。培训师包括熙华和熙神的管理人员、曾经参与过项目稽查的专业人员及业界专家。最近,受国家食品药品监督管理总局高级研修学院的委托,熙华检测将协助总局在其滁州分公司举办临床生物样本分析技术及质量标准培训。
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