1. Pre-Clinical Work
1.1. Animal trials
1.1.1. Pharmacology
1.1.2. Toxicology
1.1.3. Pharmacokinetics
1.2. Investigational New Drug (IND)
1.3. 3 to 6 years
1.4. CONSIDERATIONS for human trials
1.4.1. ADME, delivery, safety, efficacy, manufacture feasibility
1.5. Investigational New Drug (IND)
2. Clinical Trials (6-7 years)
2.1. Phase I
2.1.1. Safety and tolerability studies
2.1.2. Healthy volunteers
2.1.3. Small sample size (10s to ~100)
2.1.4. Non-blind, uncontrolled
2.2. Phase II
2.2.1. Proof of concept, "does it work?"
2.2.2. 100-500 volunteers
2.3. Phase III
2.3.1. Pivotal
2.3.2. Comparative studies against present standard of care
2.3.3. Randomized & controlled
2.3.4. 1000 to 5000, upto 10000 volunteers
2.3.5. TRIALS ~END~
2.3.6. FDA Review and Scale Up (~0.5 to 2 years)
2.3.6.1. Regulatory
2.3.6.1.1. New Drug Application (NDA)
2.3.7. Conditional versus full drug approval
2.4. Phase IV
2.4.1. Registration
2.4.2. Mass manufacturing
2.4.3. Large sample/10000s
2.4.4. Post marketing surveillance
2.4.5. Real world "effectiveness"
2.4.6. Indefinite time scale