NBScience 是一家领先的全方位服务 CRO .

Established in 2004, 国家统计局科学 specializes in regulatory affairs,

临床试验管理, 医学会议组织,

GCP, 国内生产总值, GMP certification and audit, 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

promising ideas into commercial reality.

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Clinical trials services:

Our organization offer services on arrangement and performance of clinical trials of pharmaceuticals . Preparation of reports on clinical trials in phases I-IV. Obtaining a permission to perform clinical research from Ministry of Health. Monitoring and co-monitoring of international and local clinical research phases II-IV. Arrangement and holding of initial, intermediate and final research meetings. 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.

我们的组织涉足多个领域, 这使得能够采用全面的方法来完成各种任务. 我们提供的服务如下: 必需准备品的供应, 研究中心的医疗设备和随附材料. 根据 ICH GCP 规则以及申办者的条款和条件在研究中心之间储存和分配药品. 研究完成后从临床中心收集药品: 移走或销毁药品. 在进行研究的背景下, 我公司与临床中心和研究人员签订合同, 控制合同付款并提供临床研究的法律和信息支持.

体内生物等效性

生物等效性与分子生物学实验室提供全力协助: 体内生物等效性试验设计病例报告表的准备和审查 (条件随机场) 准备知情同意书 (ICF) 议定书/修正案的准备和翻译 (符合 ANMAT, 美国食品药品监督管理局, 我, GCP) 临床研究地点和研究者的选择 监管部门的批准 (地方道德委员会, IRB/IEC, 国家监管机构 ANMAT) 药物 血浆浓度测定方法 研究与开发 方法验证 样品测定 统计分析和报告 最终临床和统计报告

The Laboratorys facilities include two ThermoSeparation HPLCs, 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, 创新产品中含有的活性成分可以由不同的实验室自由商业化.

仿制药: 是与创新产品具有相同剂型、相同定性和定量成分的药物. 必须通过生物等效性研究证明治疗等效性. 仿制药与参比药可以互换,因为它们具有相同的治疗效果. 只有当创新名牌产品的专利到期后,它们才能商业化.

欲了解详情,请通过电子邮件联系我们: head_office@nbscience.com

生物等效性研究的设计

体内生物等效性研究的设计, 重要的是要考虑以下问题: 学习目的: 药物开发, 当地监管要求, 全球市场目标, 营销. 药品特性: 用于其量化的分析方法, 药物的半衰期将决定研究时间表, 最终不良事件, ETC. 所有这些问题都会影响研究成本以及道德和监管问题. 临床研究地点和分析实验室选择: 遵守 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.

欲了解详情,请通过电子邮件联系我们:head_office@nbscience.com

标准作业程序 (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

标准作业程序 (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.

实验室清理和净化方法的标准操作程序

处理和废弃具有生物危害风险的液体的标准操作程序: 血清, 血浆和人血.

危险药物和材料处理的标准操作程序. 危险废物标准操作程序

生物危险物质运输和接收的标准操作程序

HPLC 的标准操作程序校准和维护

血浆样品冷藏运输控制的标准操作程序

称重天平维护和校准的标准操作程序

恒温槽维护和校准的标准操作程序

pH 计维护和校准的标准操作程序

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

At the Laboratory of Bioequivalence and Molecular Biology we validate the analytical methods according to ICH guidances, evaluating the following parameters:

Selectivity / specificity Precision (Precision, Intra-analysis precision, intermediate precision) Linearity and range

Limit of Detection

Limit of Quantification Accuracy / Recovery

Recovery of the plasma extraction method Stability of the drug in plasma at -20oC, room temperature and freeze/thaw cycles

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.

欲了解详情,请通过电子邮件联系我们: head_office@nbscience.com

 

关键词: 干细胞疗法,临床研究,临床实验,

临床试验,临床试验,临床研究,
临床试验, 临床试验, 临床经验
H,临床试验,临床检查,临床研究,
临床试验,临床试验,临床研究,
临床试验,临床试验,临床研究

欲了解详情,请通过电子邮件联系我们: head_office@nbscience.com

干细胞疗法