在体内新陈代谢

In vivo metabolism studies are critical to the development of your compounds. Select from flexible metabolism studies and services, ranging from high throughput PK screening of compound libraries through definitive dose linearity and escalation/tolerability ahead of safety assessment or your IND/CTA filing. We also offer formulation bridging studies, experience with bioequivalence and biosimilars, as well as radiolabel distribution, excretion and metabolite identification.

能力概述

  • Global network of in vivo sites to offer fast study starts and maximum flexibility
  • Thousands of dose initiations annually at global sites
  • 标准和非标准动物模型的经验
  • 从高吞吐量到明确和调查/研发的高吞吐量的各种研究类型

In addition to offering a full suite of in vivo metabolism studies required to answer regulatory questions, we provide assistance with regulatory consutling or writing assistance for regulatory documentation.

许多赞助商也与我们密切合作,获得广告vice on which investigative studies to select or which studies would best target mechanistic insights for their compounds.


快速的pk.

从剂量到PK数据,只需5天或更短。在药物发现的早期阶段迅速筛选大量化合物,以制定更快的决定。

在快速pk下载我们的小册子

PK and PK/PD

高通量筛选,配方筛选,非GLP / GLP,剂量升级/线性,药效动物,耐受性,调查等等。。。

生物等效/生物纤维单模

为您的生物等效性获得具体的监管建议生物纤维单模工作。我们的专家提供适当供电的学习设计的见解和指导,以及提交就绪数据和报告,完整的统计数据。

股票和客户拥有的殖民地

We maintain colonies of non-naïve dogs and NHPs across global sites for both large and small molecule development in order to offer quick study starts. In addition to our colonies, clients sometimes choose to use a dedicated client-owned colony for intact and surgical (BDC, PVC, CSF) options. Tracking of molecule class (small and large molecules) enables efficient and sustainable animal re-use as part of our3R哲学

手术和研发

内部,专业的外科团队可以直接与您直接工作,涉及外科修改的研究。从团队中选择标准提供或创新以执行研发。

质量平衡

口服,IV,皮下,肌肉内,鞘内,鼻内,皮肤和局部眼镜行政管理用于确定放射性标记化合物的吸收,分布,新陈代谢和排泄。

我们提供定制设计的专业知识,并使用大规模平衡研究14C,3.H,125一世,111In, and131一世,or other non-traditional radioisotopes.

眼部分布

The utilization of a radioisotope can provide specific ocular biodistribution information for your test article from selected ocular tissues. Get unrivalled expertise conducting radiolabeled ocular studies using ocular specific dose routes (topical, intravitreal, intracameral, superchoroidal, subretinal); animal species with tissue collection as well as quantitative autoradiography and microautoradiography end points.

放射性药物和放射治疗剂

使用Gamma,Beta和α放射性同位素和成像剂获得定制分布,排泄和新陈代谢研究,用于您的放射性药物需求。所有研究都对适用的联邦核监管委员会(NRC)或国家发布的辐射许可证要求进行。

定量全身放射自显影(QWBA)

Distribution of therapeutic agents in the whole body or anatomical substructures can be determined through the use of low‑ or high‑energy emitting radioisotopes, including3.H,14C,125一世,131一世,3.5s,和99.TC。行业领先的全球QWBA科学家生产量的定量结果和定性图像,以便随着时间的推移描绘分布,保留/积累和消除放射性标记的化合物。

除了使用许多临床前测试物种外,我们的科学家还与肿瘤模型和特定器官或yaboapp体育官网胎儿胎儿,胎盘转移模型,关节或眼组织一起使用。

yaboapp体育官网临床前组织分布数据可用于计算人类剂量计量估计和使能人体大规模平衡临床研究在全球的我们的临床研究单位之一使用您的放射性标记化合物。

Human AME

人放射性标记的吸收,代谢和排泄(人类ame.研究提供

  • definitive information about mass balance and routes of elimination,
  • 完全了解药物的新陈代谢结构(包括人和动物代谢物的比较,以确定是否有保证额外的动物测试),和
  • a determination of the ratio of parent drug to metabolite(s) in circulation.

In order to correctly identify hAME, our team of nuclear pharmacists, radiation safety committee members, medical doctors, and DMPK scientists work together with clients and sponsors to develop customized study designs that follow requirements from global regulatory authorities [e.g., FDA (including MIST, ICH) and EMA] for using a radiolabeled test compound. Merging scientific and regulatory components are critical to successful execution of a human AME study.

快速分析样品的能力是HAME研究的关键。在美国,我们在威斯康星州之间的共享校园phase 1 clinical unit和DMPK放射分析实验室允许提供实时放射分析结果以管理主题的可变性,并促进及时的主题释放。在英国,除了正常健康的志愿者之外,DMPK实验室和临床部门还有医院合作成功完成患者人类AME研究。

我们已经开展了350多个人类艾米研究,获得了数十年的经验,以指导成功的学习执行。

辐射剂量测定

我们使用辐射曝光的建模,以支持放射性标记分子的人类吸收,新陈代谢和排泄(HAME)临床试验。

Dosimetry科学家使用临床前的组织分布数据,yaboapp体育官网与适用的法规和指导,管理人类剂量季度(ICRP),美国食品和药物管理局(FDA)和世界卫生组织(WHO)。

Our scientific team determines a safe radioactive dose level to be administered during the human radiolabeled mass balance and pharmacokinetic (PK) study.

The radioactive dose level and calculated radiation exposures to individual tissues and the whole body may be submitted to institutional review boards and ethics committees across the US and Europe for approval to conduct a人放射性标记的临床研究。

所有体内代谢研究都在我们的AAALAC认可的设施中进行,我们重视animal welfare作为我们的最高优先级,创造了一种护理文化,支持3RS。

Dose Routes
  • 盒式磁带和离散剂量
  • 静脉内(推注,输液)
  • 口服(饲料,胶囊/平板电脑,饮食)
  • 皮肤,皮内
  • 眼镜
  • 腹膜内
  • Intramuscular
  • Subcutaneous (bolus, infusion)
  • 舌下
  • Intracerebroventricular
  • 鞘内
  • 吸入,鼻内
  • intravise
  • Intra-articular
  • R&D upon request
  • 设备/surgical
采样
  • 血液(血浆,血清)
  • 排泄物(尿液,粪便)
  • 胆汁
  • 组织
  • PBMC
  • CSF(串行生存,终端)
  • 乳房排泄
  • 滑膜液
  • 拭子
  • BALF
  • 序列活组织检查:
    • 皮肤
    • 肌肉
    • 骨髓
    • Lymph nodes
  • R&D upon request