Creating new medicines is a challenging, costly, high-risk undertaking, and one that can take 10-15 years and cost more than $1 billion. The therapeutic focus of Janssen R&D helps promote efficiency and operational excellence within the drug discovery and development processes to help us deliver innovative solutions to patients worldwide.
To see how a medicine is developed, watch "From Molecule to Medicine".
The first step in transforming a molecule into a drug is evaluation in pre-clinical (pre-human) testing, which establishes the effectiveness and safety of the molecule in systems which mimic those present in humans:
- Phase 1 - Perform initial human testing in a small group of healthy volunteers.
- Phase 2 - Test in a small group of patients.
- Phase 3 - Test in a large group of patients to show safety and efficacy.
If a drug passes through these various stages with good results of efficacy and safety, it is submitted to the appropriate government agencies for review.
- Phase 4 (post-market) – After a product has been approved, more studies are conducted to provide additional information about safety and effectiveness.