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Drug Metabolism and Pharmacokinetics (DMPK) Consulting Services

Drug Metabolism and Pharmacokinetics (DMPK) Consulting Services

Certara provides nonclinical and clinical DMPK drug development consulting to support a wide range of offerings to help advance your compounds from candidate selection, through IND enabling, to clinical development. Our DMPK services team can support your lead optimization programs, help you design and build an IND/CTA package, and even provide post-first-in-human (FIH) program support. Our early development experts can create and outline an IND-enabling strategy for nonclinical DMPK, including a regulatory strategy, timelines, and budgets.  

신약 개발

  • 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

The Certara team integrates its DMPK expertise with advanced modeling, simulation, and bioanalytics to optimize drug development, mitigate risks, and streamline regulatory approvals.

Learn more about our DMPK Services

Streamline Drug Discovery and Development with Certara’s Expert DMPK Services

For a seamless transition to the clinic, our team can strengthen your early development strategies by supporting FIH dose selection, clinical PK sampling scheme, and appropriate co-medication exclusion(s).



Request Tailored Nonclinical Plans

We offer variable levels of support, from resolving single challenges, doing gap analyses, to becoming an extension of your team. Our programs are tailored for your individual program requirements.

Access Collaborative Solutions That Meet Regulatory Scrutiny 

A single engagement at Certara can easily provide access to our many drug development experts. Together with CMC, Toxicology, Clinical Pharmacology, and Regulatory Strategy teams to deliver comprehensive support.  



Leverage Specialized DMPK Expertise 

Certara’s DMPK services team have over 100 years of collective experience in various modalities/indications, potentially offering you support in multiple programs.

Early Development DMPK Services

  • 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 (study plans, IND, IB, End of Phase meetings, publications etc.)
  • DMPK/ADME study conduct support including:
    • ADME studies – radiolabel and non-labeled
    • Bioanalysis (supporting small and large molecules)
    • DDI and in vitro metabolism/transporter support
    • Phenotyping, Metabolite profiling/MIST support
    • Clinical AME support including dosimetry

Learn more about our DMPK & ADME Consulting Services

Meet Our Experts

Nathalie Rioux

Vice President, Head of DMPK

Nathalie provides strategic DMPK & ADME discovery services, nonclinical DMPK, clinical pharmacology, and regulatory sciences for several biotechnology companies. She is also a Core Team Member of the Center of Excellence in Drug Interaction Science.

Nathalie obtained her Ph.D. in Pharmacy at Laval University, Quebec, Canada, where she studied lung cancer chemoprevention and completed a post-doctoral fellowship in drug metabolism. Nathalie has more than 20 years of experience in the pharmaceutical industry, in biotech, pharma, and CRO service. After being a DMPK lab head & project leader for multiple antiviral drug development projects at Boehringher Ingelheim, she moved to a principal DMPK scientist role at Epizyme. Most recently, she built the DMPK, bioanalytical and clinical pharmacology group at H3 Biomedicine, where she drove the strategic and tactical activities across the discovery and development space.


Dennis P. Heller, PhD

Sr. Director, Early Drug Development Services

In his current role with Certara, Dr. Heller provides consultancy services to pharmaceutical and biotech companies in the areas of non-clinical and clinical DMPK/ADME studies, including acting as project lead or strategic consultant to design and manage IND and NDA-enabling ADME programs for drug metabolism, PK, DDI, and radiolabel studies, project management, vendor management, report review and preparation, gap analysis, allometry, as well as conduct human radiolabel dosimetry estimations. In addition, Dr. Heller may provide an operational role as a virtual project team representative.

Dr. Heller has over 20 years’ experience providing scientific/technical leadership, consultancy and operational CRO management to enable a platform of ADME and bioanalytical services, with depth in radiolabel studies from in vitro, non-clinical to clinical hAME studies and dosimetry.

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