Certara’s DMPK Services integrate advanced modeling, simulation, and bioanalytics to propel your drug development process forward. From lead optimization to IND-enabling strategies and post-first-in-human (FIH) support, we provide a tailored approach to meet your program-specific requirements. Our expert team helps navigate regulatory scrutiny, mitigates risks, and accelerates timelines through evidence-based methodologies.
药物代谢与药代动力学（DMPK）咨询服务
Certara's professional DMPK Services provide cutting-edge solutions to support your drug development from candidate selection to clinical success.
Learn more about DMPK Consulting Services
Streamline your drug development with Certara’s expertise
Innovative lead optimization
Leverage in silico modeling and in vitro studies for strategic lead optimization.
Regulatory-ready IND packages
Comprehensive support in preparing IND/CTA packages with clear timelines and budgets.
Advanced PK/PD modeling
Predict human PK and exposure-response relationships with precision.
End-to-end collaboration
Access expertise across DMPK, CMC, Toxicology, and Regulatory Strategy teams.
Pioneering strategies tailored for success
Our early development DMPK-related solutions
药物发现
In silico modeling
In vitro studies
临床前开发
药代动力学 (PK) 研究
生物分析技术支持
毒代动力学（TK）
早期临床阶段
人体 PK 研究
群体 PK/PD 模型
药物相互作用 (DDI) 预测
晚期临床开发
基于生理的药代动力学（PBPK）建模
暴露-反应关系
批准后
上市后监测
监管支持
不同药物研发阶段的差距分析
DMPK/ADME 先导优化、IND 授权和转化开发计划
DMPK/ADME/转化研究及项目团队代表
PK 和 PD 数据分析与建模
PK 结果和模型分析的解释和应用
人体 PK 预测
PK/TK 研究分析和报告
静态 DDI 风险评估（根据 ICH M12）
DMPK/ADME writing
DMPK/ADME study conduct support
Introducing our DMPK leaders
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Certara’s DMPK Services team is ready to support your drug development needs. Whether you require lead optimization, IND preparation, or advanced modeling solutions, our experts are here to guide you every step of the way.
Proven expertise across nonclinical and clinical phases.
Advanced modeling and simulation tools for precise predictions.
Tailored solutions to meet regulatory scrutiny with confidence.
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常见问题解答
What does Certara’s DMPK services include?
Our services encompass drug metabolism studies, bioanalysis, DDI risk assessments, PK/PD modeling, and regulatory support.
How does Certara ensure regulatory compliance?
Certara’s team has extensive experience navigating global regulatory frameworks, ensuring all submissions meet required standards.
Can Certara tailor its DMPK services to individual projects?
Yes, our solutions are fully customizable to align with your specific program requirements
