All are true about Phase II trials except:
Ans: B (Done in healthy human volunteers) Ref: Goodman and Gilman's "Pharmacological Basis of Therapeutics" 12th edExplanation:Phase II trial is done on Patients (Phase I done on healthy human volunteers)It is done for assessing the safety and efficacyIf Phase I trial indicates any serious adverse effects. Phase II cannot be donePositive evidence and absence of serious adverse effects from Phase I are prerequisite for proceeding with Phase II trial. (See the following table and figure)
Clinical Trials
Safety and efficacy
Done in healthy human volunteers
Therapeutic exploratory trial
Positive evidence in Phase 1 is a prerequisite
Done in healthy human volunteers