1. Clinical Research

2. Preclinical Study
• Before testing on humans
• Either in vitro or in vivo
• Toxicology
• Pharmacology
• Metabolism
• Bio analysis
• Pharmaceutical analysis
• Biosafety

3. Clinical Trials
• Systematic Study od Pharmaceutical
Products
• On Humans :Patients OR Non-
Patient Volunteers
• Verify Clinical,Pharmacological and
Adverse Effects
• Determine Safety and Efficacy

4. Phase I
• Human/Clinical Pharmacology Trials
• Maximum Tolerated Dose
• Pharmacodynamic,Pharmacodynami
cs,
• Adverse Reactions:Nature &
Intensity
• Healthy Adult Volunteers

5. Phase II
• Exploratory Trials
• Limited Number of Patients
• Possible Therapeutic Uses
• Effective Dose Range
• 10-12 Patients at Each Dose
• Safety and Pharmacokinetics

6. Phase III
• Confirmatory Trials
• Efficacy and Safety in larger
number of patients
• Comparision: Standard
Drug/Placebo
• Adverse Drug Reactions and
Efficacy
• Atleast 100 patients over 3-4
centers

7. Phase IV
• Basis: Product characteristics on
which Market Authorisation was
granted
• Post-marketing surveillance
• Assessment of therapeutic value
• Treatment strategy and safety profile
• Explore
 New indications
 New methods of administration or
Combination