Drug Discovery Process
From initial discovery to a marketable medicine is a long, challenging road. It takes about 12 - 15 years from discovery to the approved medication and requires an investment of about US $1 billion. On average, from more than a million screened molecules only one is investigated in late stage clinical trials and is finally made available for patients.
Overview of the process steps
Research
- Target identification and validation
- Assay development
- Lead identification
- Lead optimisation
- Pre-development
Development
- Preclinical development
- Clinical research phase I to phase III
Registration
- Regulatory approval
- Phase IV (Life cycle management)