Question

Please prepare a brief description of the reasoning for your choice of answer.

1)What is not typically measured during a Phase I clinical trial?

a)The safety profile of the drug candidate when used in healthy subjects

b)A clinical endpoint to estimate the drug’s candidates effectiveness

c)The maximal tolerable dose of the drug candidate

d)The absorption, distribution, metabolic, and excretion properties of a drug candidate

2)Which of the following is incorrect regarding the successful completion of Phase III clinical trials?

a)Efficacy of the drug candidate in a large number of patients, usually thousands, has been confirmed

b)The drug has been tested in patients with anticipated comorbidities but not under all comorbidity circumstances

c)The full adverse drug effect profile on the population in which the drug is to be used is known

Answer 1

(1) answer÷ [b]

Explanation÷ phase 1 of the clinical trial of drug mainly checks the safety of drugs given to the volunteer. In this phase as doses increased side effect is analyzed and also the absorption, excretion and other metabolic effect evaluated.

But the clinical end point is not studied in phase 1 , end point study is mostly done in the last phases of clinical drug tarial.

(2) answer [b]

Explanation÷ In phase 3 of clinical trials drug is tested for other comorbidity too, for example drug may be tested even for kidney, heart or liver disorder.