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定量药理学服务

优化药物开发与监管决策

Available for both standard and expedited timelines for NDA, BLA, and MAA submissions

利用 Certara 定量药理学服务推进药物开发

Pharmacometrics integrates knowledge of drug exposure and response to support dose selection, safety, and efficacy. Our global team applies advanced population pharmacokinetic (PopPK), pharmacokinetic-pharmacodynamic (PK/PD), and exposure–response modeling to inform development decisions and accelerate clinical programs.

We deliver the full range of pharmacometrics analyses required for regulatory submissions, helping sponsors optimize trial design, support dose justification, and generate evidence across diverse patient populations, including special populations, such as pediatric and rare disease patients. These approaches are increasingly central to model-informed drug development (MIDD) and evolving regulatory frameworks such as ICH M15.

Our Pharmacometrics capabilities

Data-driven development decisions

Apply quantitative modeling frameworks to inform dose selection, evaluate variability in drug response, and support confident development decisions.

Optimized clinical trial design

Leverage pharmacometrics modeling to design more efficient studies and evaluate dosing strategies to improve likelihood of success.

Special populations expertise

Support dosing and development strategies for complex populations, including pediatric, rare disease, and organ impairment populations.

Regulatory-ready pharmacometrics analysis

Deliver high-quality PopPK, PK/PD, and exposure–response analyses aligned with regulatory expectations, including MIDD and ICH M15.

Pharmacometrics for special populations

Many development programs must address populations that are difficult to study through traditional trials. Pharmacometrics enables sponsors to integrate available data and generate quantitative evidence to inform dosing and treatment strategies.

Modeling approaches are particularly valuable for:

  1. Pediatric populations
  2. Rare disease populations
  3. Patients with renal or hepatic impairment
  4. 老年人口
  5. Pregnant or lactating patients

These models integrate diverse data sources to evaluate exposure, predict variability, and support regulatory decision-making.

汇聚全球顶尖定量药理学专家与技术,赋能卓越药物开发洞见

Our pharmacometrics team designs and implements MIDD strategies across therapeutic areas, drug modalities, and development phases. We support programs for diverse populations, including pediatric and rare disease patients, while delivering analyses that are fully aligned with regulatory expectations and ready for submission across both standard and accelerated timelines.

最大的全球专家网络

120+ 位拥有博士、药学博士及医学博士学位的顾问,覆盖各治疗领域与开发阶段,Certara 提供无与伦比的专业实力

监管成功实证

美国 FDA 批准的新药中,90% 以上采用了 Certara 软件与服务

高质量数据集

Certara 数据程序员确保数据集可即时用于符合用途的 PK 及 PK/PD 建模

The ICH M15 is finalized. Is your MIDD strategy aligned?

The ICH M15 guideline harmonizes global expectations for model-informed drug development. From early planning and Model Analysis Plans to submission-ready documentation, sponsors must demonstrate structured, credible modeling strategies.

Explore our expert resources below and connect with our Pharmacometrics team to ensure your approach aligns with the new framework.

为什么选择 Certara?

Certara 是定量药理学服务领域的领军者,集专业知识、创新技术及严谨方法于一体,提供符合监管要求的解决方案,优化药物开发决策。我们的团队经验覆盖药物开发全周期,确保提供精准、数据驱动的洞见,助力实现商业成功最大化。

120
位定量药理学顾问,覆盖全球五大洲
800
项定量药理学项目,过去四年内完成

携手 Certara,汇聚全球经验最丰富的定量药理学团队。我们的专家致力于提供创新且符合法规的解决方案,助力优化药物开发成果。

120+ 位定量药理学专家实证专业积淀
运用高质量数据集与先进定量方法赋能精准分析
以数据驱动决策,全阶段最大化成功概率

与专家对话


常见问题解答

什么是定量药理学?

定量药理学通过数学建模量化药物与患者间的相互作用,为监管决策提供支持并优化药物开发。

Certara 如何支持监管申请?

Certara 提供符合监管要求的 PK/PD 分析与建模服务,确保申报材料完整可靠。

Certara 支持哪些药物开发阶段?

Certara 支持全阶段开发,涵盖临床前、早期临床及后期临床阶段。

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