Question:
Phase I trial is critical especially due to:
Phase I trial is critical especially due to:
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Phase 1 = Safety (Small group of healthy people).
Updated On: May 15, 2026
- Efficacy
- Marked surveillance
- Safety and tolerated dose
- Long term study
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The Correct Option is C
Solution and Explanation
Step 1: Concept
Clinical trials are conducted in sequential phases to evaluate a new drug before it is approved for public use.
Step 2: Meaning
Phase I is the first time a drug is tested in humans (usually healthy volunteers).
Step 3: Analysis
The primary objectives of Phase I are to determine the safety profile, find the maximum tolerated dose (MTD), and understand the pharmacokinetics in humans. Efficacy is tested in later phases (Phase II and III).
Step 4: Conclusion
Phase I is most critical for establishing basic safety and dosage. Final Answer: (C)
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