NBScience 是一家领先的全方位服务 CRO .
成立于 2004, 国家统计局科学 专门从事监管事务,
临床试验管理, 医学会议组织,
GCP, 国内生产总值, GMP认证和审核, 数据管理,
制药咨询和医学写作服务.
制药用, 生物技术, 仿制药, 和医疗器械
世界各地各种规模的公司, NBScience 可以帮助您转型
将有希望的想法转化为商业现实.
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临床试验服务:
我们的组织提供药物临床试验的安排和实施服务 . 准备I-IV期临床试验报告. 获得卫生部的临床研究许可. 国际和本地临床研究II-IV期的监测和共同监测. 初始资金的安排和持有, 中期和最终研究会议. Designing of phases I-IV.
Data acquisition and management Data input and verification Data validation Data quality assurance and generation of requests to research centers Consultations, development and carrying out the statistical analysis of clinical trials Preparation of statistical, medical and integrated reports on respective trials Data safety and confidentiality NBScience offers its services on performance of laboratory tests in the context of clinical trials in phases II-IV in one Central laboratory
Cutting-edge laboratory equipment
National certificates for all types of analyses. Performance of the following laboratory studies: overall blood analysis , biochemical analysis , lipid profile, coagulation status,diabetic indices, immune markers , hormonal status, Storage of samples for laboratory studies during 7-10 days to perform their re-tests. A range of services rendered by our company includes the approval of laboratory tests for a report and development of laboratory research instructions.
Our organization is engaged in multiple fields, which enables for a comprehensive approach in accomplishing various tasks. The services offered by us are as follows: Supplies of essential preparations, medical equipment and accompanying materials to research centers. Storage and distribution of pharmaceuticals among research centers in accordance with ICH GCP rules and a sponsor’s terms and conditions. Collection of pharmaceuticals from clinical centers after the completion of their studies: removal or destruction of pharmaceuticals. In the context of performing the studies, our company forms the contracts with clinical centers and researchers, controls payments under contracts as well as provides a legal and information support of clinical studies.
In Vivo Bioequivalence
The Laboratory of Bioequivalence and Molecular Biology provides full assistance in: In vivo bioequivalence trial design Preparation and review of Case Report Forms (CRFs) Preparation of Informed Consent Form (ICF) Preparation and translation of the Protocol/ammendments (in compliance with ANMAT, 美国食品药品监督管理局, 我, GCP) Selection of the clinical study site and investigators Regulatory approvals (Local Ethics Committee, IRB/IEC, National Regulatory agency ANMAT) Drug Plasma concentration determination method Research and development Method validation Sample determination Statistical analysis and report Final clinical and statistical report
该实验室的设施包括两台 ThermoSeparation HPLC, 带自动进样器和可变波长紫外检测器. 我们还提供使用其他检测方法分析样品的可能性, 如气相色谱仪, 液质联用/质谱, 放射免疫分析, 环境影响评估, ETC. HPLC 和所有其他支持设备 (离心机, 秤, 蒸发器, ETC) 根据全球一致的标准操作程序定期校准 (标准操作程序).
类似或仿制药?
原创或创新药物: 是含有经过完整研究和开发的新活性成分的产品. 因此它是第一个, 有时是唯一的一个, 有助于建立自己的安全性和治疗效果数据. 发展中的, 权利专有实验室, 以注册品牌名称将其商业化. 一旦专利权到期, the active ingredients contained in innovator products can be commercialized freely by different laboratories.
A generic drug: is a medicine with the same pharmaceutical form and equal qualitative and quantitative composition than the innovator product. It must demonstrate therapeutic equivalence by means of bioequivalence studies. The generic drug is interchangeable with the reference product since they have the same therapeutic effectiveness. They can only be commercialized once the patent of the innovator brand-name product has expired.
For details please contact us by e-mail: [email protected]
Design of a Bioequivalence Study
In the design of an In vivo Bioequivalence study, it is important to consider the following issues: Study Purpose: drug development, local regulatory requirements, global market goals, marketing. Drug characteristics: analytical method to be used for its quantization, half life of the drug that will determine the study timelines, eventual adverse events, ETC. All these matters affect both study costs and ethical and regulatory issues. Clinical Study Site and Analytical Laboratory selection: compliance with GCP, 良好实验室规范, SOPs and certifications. Study population: number of volunteers to be enrolled in the study, depending on the aims of the study and drug variability, which can be estimated from bibliography or a pilot study. Study design: simple cross-over (AB/BA) or replicate (ABAB/BABA). The replicate design reduces the sample size (N) but lengthens study times. Group sequential design may also be proposed.
For details please contact us by e-mail:[email protected]
Standard Operating Procedures (标准操作程序)
In compliance with Good Laboratory Practices (良好实验室规范), the Laboratory of Bioequivalence and Molecular Biology has created the following
Standard Operating Procedures (标准操作程序) which are constantly revised and updated.
Standard Operating Procedures for the Validations of analytical methods
Standard Operating Procedures for use and maintenance of Laboratory Notebooks Authorized personnel for calibration and maintenance of Laboratory equipment.
Standard Operating Procedures for methods of clean-up and decontamination in the Laboratory
Standard Operating Procedures for handling and waste of fluids with biological hazard risk: serum, plasma and human blood.
Standard Operating Procedures for handling of hazardous drugs and materials. Standard Operating Procedures for Hazardous waste
Standard Operating Procedures transport and reception of biological hazardous materials
Standard Operating Procedures calibration and maintenance of HPLC
Standard Operating Procedures for the control of refrigerated transport of plasma samples
Standard Operating Procedures for maintenance and calibration of Weigh Balances
Standard Operating Procedures for maintenance and calibration of thermostatic bath
Standard Operating Procedures for maintenance and calibration of the pHmeter
Standard Operating Procedures for maintenance and calibration of the N2-evaporator Standard Operating Procedures for the use and calibration of micropipettes
Standard Operating Procedures for guidelines of sample re-analysis criteria
Standard Operating Procedures for records and archives
Standard Operating Procedures for preparation and review of standard operating procedures
Validated Methods
在生物等效性和分子生物学实验室，我们根据 ICH 指南验证分析方法, 评估以下参数:
选择性 / 特异性 精确度 (精确, 分析内精度, 中间精度) 线性度和范围
检测限
定量准确度限制 / 恢复
血浆提取方法的回收 -20oC 血浆中药物的稳定性, 室温和冷冻/解冻循环
现在, 我们已经验证了以下抗逆转录病毒药物的分析方法，目前我们正在根据客户的需求进行同时测定抗逆转录病毒药物和其他药物的验证.
For details please contact us by e-mail: [email protected]
关键词: 干细胞疗法,临床试验,临床实验,
临床试验,临床试验,临床研究,
临床试验, Клінічне випробування, تجربة سريري
ة,Assaig clínic,Klinisk undersøgelse,Klinische Studie,
临床试验,Ensayo clínico,Kliininen tutkimus,
Essai clinique,ניסוי קליני,Studio clinico
For details please contact us by e-mail: [email protected]