
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

