Smarter Drug Development – Look through a new lens (PK/PD)

Look at Drug Development Through a New Lens

Drug Development - a new lens

 

Smarter drug development starts with designing your program around a solid understanding of how your drug interacts with the body. Simply put, understanding your drug’s pharmacokinetics, or PK, (the body’s effect on the drug) and pharmacodynamics, or PD, (the drug’s effect on the body) is crucial.

Started as an organization to specializing in PK/PD, Nuventra Pharma Sciences has become the go-to resource for help with PK/PD AND drug development. Clients have experienced how building their drug development program around a solid foundation of understanding their drug’s PK/PD profile leads to:

  • Better nonclinical and clinical study designs
  • Better strategic planning for regulatory affairs and clinical studies
  • Fewer costly missteps in drug development and faster ‘Time-to-Market’
  • Improved decision making based on data and science


Anyone can claim to help you with drug development, we encourage you to look at the process through a new lens…a PK/PD one.

Contact Nuventra’s team today to see how we can help you.

Our Capabilities

  • Regulatory Services

    Agency meeting representation & preparation
    CTD/eCTD submission
    Guidance document interpretation
  • Phase 1 Clinical Support Services

    Phase 1 Unit Identification
    Protocol Development and Management
    Evaluation Visits and Site Qualification
    Study Start-up & Execution Support
  • PK, PD & Population PK Services

    Traditional Noncompartmental Analysis
    Modeling & Simulation
    Model Based Drug Development
    Automated Model Selection
  • Toxicokinetics (TK) Services

    GLP and Non-GLP TK analysis
    Automated analysis and report generation (eTK)
  • Scientific & Medical Writing Services

    PK/PD, TK, and Population PK Report
    Phase 1 Clinical Study Report (CSR)
    New Drug Application (NDA)
    Abbreviated New Drug Application (ANDA)
    Biologics License Application (BLA)
    New Drug (IND) Application
    FDA Meeting Briefing Package
    Orphan Drug Application
    Investigator Brochure
  • Non-Clinical Support Services

    Nonclinical Plan Development
    Strategic Advice on IND-enabling studies
    Vendor Identification (BA, CMC, Toxicology, etc.)