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.
薬物代謝および薬物動態（DMPK）コンサルティングサービス
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
創薬
In silico modeling
In vitro studies
前臨床開発
薬物動態（PK）試験
バイオアナリシス
毒性動態（TK）
初期臨床開発
ヒト薬物動態（PK）試験
母集団薬物動態/薬力学（PK/PD）モデリング
薬物相互作用（DDI）予測
後期臨床開発
PBPKモデリング
曝露反応関係
市販後
市販後調査
レギュラトリーサポート
医薬品開発の各段階に応じたギャップ解析
DMPK/ADMEリード最適化、新薬臨床試験開始申請（IND）対応、トランスレーショナル開発計画
DMPK/ADME/トランスレーショナル・スタディおよびプロジェクトチームのリーダー
PK/PDデータ解析とモデリング
PK結果およびモデリング解析の解釈と応用
ヒトPK予測
PK/TK試験の解析および報告
静的DDIリスクアセスメント(ICH M12)
DMPK/ADME writing
DMPK/ADME study conduct support
Introducing our DMPK leaders
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エキスパート
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エキスパート
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全て見るGet in touch with Certara’s DMPK team
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.
一度サターラにご相談ください
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FAQs
What does Certara’s DMPK services include?
Our services encompass drug metabolism studies, bioanalysis, DDI risk assessments, PK/PD modeling, and regulatory support.
サターラは、どのような体制で規制要件への適合を実現しているのでしょうか？
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
