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Services
IAM is a contract research organization who offers drug analytical services specializing in quality testing and pharmacokinetics.
At each step:
Basic research
Compounds are investigated to find potential drug "seeds", optimized, and then further screened to identify promising leads.
Nonclinical study
Efficacy and safety of candidate compounds are investigated. Once a compound is found to show promise, drug formulation for clinical use (i.e., tablet, liquid, etc.) is investigated.
Clinical study
Efficacy and safety of candidate compounds on humans are investigated in Phase I to III studies, and the collected data are analyzed to assess the utility of the potential new drug.
Application for approval
The pharmaceutical company submits a new drug application to the Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA reviews its efficacy, safety and quality for manufacturing and marketing approval.
Post-marketing study
The effectiveness and safety of the new drug are followed up for 4 to 10 years after marketing, and the results are reported to the Ministry of Health, Labor and Welfare.