Product Development Plan

  • Research and Development

    • Conduct extensive literature review and patent searches

    • Develop proprietary non-nephrotoxic formulation

    • Perform in vitro and animal studies to establish safety and efficacy

  • Preclinical Studies

    • Comprehensive toxicology studies

    • Pharmacokinetic and pharmacodynamic analyses

    • Imaging effectiveness studies in animal models

  • Clinical Trials

    • Phase I: Safety and dosage studies in healthy volunteers (6-12 months)

    • Phase II: Efficacy studies in patients undergoing diagnostic imaging (12-18 months)

    • Phase III: Large-scale comparative studies against current contrast agents (18-24 months)

  • Regulatory Approval Process

    • Submit New Drug Application (NDA) to FDA

    • Apply for CE Mark in Europe

    • Pursue approvals in other key markets (Japan, China, etc.)

  • Manufacturing Scale-up

    • Develop and validate GMP-compliant manufacturing process

    • Establish quality control and assurance protocols

    • Secure manufacturing partnerships or build in-house facilities

Simplified Product Development Plan