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)
Safety and efficacy
Done in healthy human volunteers
Therapeutic exploratory trial
Positive evidence in Phase 1 is a prerequisite
Clinical Trials