Phase II clinical trial | NEET Based MCQ

True about phase II clinical trial is 

A. Large number of patients are included 
B. Therapeutic efficacy 
C. Toxicity 
D. Safety

Ans. D. (Therapeutic efficacy)
Explanation

Phase I (Pen label/Non blind)
• Done on normal volunteers; who are with renal and hepatic impairment
• It determines human pharmacology and safety and tells about safety, biological effects, metabolism, kinetics, metabolism and drug interactions
• Ethical approval is required
Phase II (Single/Double blind)
• Done on selected patients
• it determines therapeutic exploration and dose ranging and tells about therapeutic efficacy, dose range metabolism and kinetics
• Ethical approval is required
Phase III (Double blind)
• Done on large sample.of selected patients
• It determines therapeutic confirmation and tells about the safety and efficacy
• Ethical approval is needed
Phase IV
• Patients are given drugs for their treatment
• it determines post marketing surveillance and tells about the adverse reactions, patterns of drug utilization and other indications are thus discovered
• No ethical approval is required