Clinical Trial Phase

Clinical trial phase evaluates drug safety, dosage, and effectiveness in humans through structured studies.

Clinical Trial Phase

Involves systematic testing in humans, divided into several phases:

Phase 0 (Optional):

• Microdosing studies in a few volunteers
• Assesses basic pharmacokinetics and drug-target interaction

Phase I:

• Conducted in healthy volunteers (20–100)
• Focuses on safety, tolerability, and pharmacokinetics
• Determines the maximum tolerated dose

Phase II:

• Conducted in patients with the target disease (100–300)
• Assesses efficacy, optimal dose, and short-term side effects

Phase III:

• Large-scale studies (1,000–3,000 or more patients)
• Confirms effectiveness, compares with standard treatments
• Monitors for rare or long-term side effects
• Data used for submitting New Drug Application (NDA)

Phase IV (Post-Marketing Surveillance):

• Conducted after drug approval and marketing
• Evaluates long-term safety, efficacy, and detection of rare adverse effects
• Helps refine dosing and usage recommendations

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