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.
Drug Metabolism and Pharmacokinetics (DMPK) Consulting Services
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
Drug discovery
In silico modeling
In vitro studies
Pre-clinical development
Pharmacokinetic (PK) studies
Bioanalytical support
Toxicokinetics (TK)
Early clinical phase
Human PK studies
Population PK/PD modeling
Drug-drug interaction (DDI) predictions
Late clinical development
Physiologically-based pharmacokinetic (PBPK) modeling
Exposure-response relationships
Post-approval
Post-marketing surveillance
Regulatory support
Gap analyses for different stage of drug development
DMPK/ADME lead optimization, IND-enabling and translational development plans
DMPK/ADME/translational representative for study and project teams
PK and PD data analysis and modeling
Interpretation and application of PK results and modeling analyses
Human PK projection
PK/TK study analysis and reporting
Static DDI risk assessment (per 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.
Contact us today
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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.
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
