Pre-clinical studies

Step 1: Screening for new clinical entities

Pre-clinical studies

Step 2: Discovering of new chemical entities

Pre-clinical studies

Step 3: Animal pharmacology: toxicity and re-productivity

Pre-clinical studies

Step 4: Toxicity studies: embryo-fetal and perinatal: mutagenicity and carcinogenicity

Pre-clinical studies

Step 5: Chemical, pharmaceutical and biological testing

Clinical studies

Step 6: Phase I: bio-availability: healthy volunteers.

Clinical studies

Step 7: Phase II: dose ranging—patents

Clinical studies

Step 8: Phase III: safety and efficacy

Clinical studies

Step 9: Launch