ICH E8 UPDATED ACTUAL Test Questions
And Correct Answers
What are examples of a Human Pharmacology study? - CORRECT ANSWERS Single and multiple
dose PK and/or PD studies
Dose-tolerance studies
Drug interaction studies
Early Measurement of Drug Activity
Dose response exploration studies are examples of what kind of trial? - CORRECT
ANSWERS Therapeutic Exploratory
The following studies describe what kind of trial?
- Comparative effectiveness studies
- Pharmacoeconomic studies - CORRECT ANSWERS Therapeutic Use
What are characteristics of a human pharmacological study? - CORRECT ANSWERS Usually have
non-therapeutic objectives
Initial administration to humans
Estimate initial safety and tolerance
Toxicity in Humans
Early Measurement of drug activity
Pharmacokinetics: Body's effect on the drug
-Pharmacodynamics: Drug's effect on the body
Pharmacokinetics: Body's effect on the drug
-Pharmacodynamics: Drug's effect on the body
What phase are Human Pharmacology studies? - CORRECT ANSWERS Phase 1
, What are characteristics of a Initial Safety and Tolerability study? - CORRECT ANSWERS Usually
intended to determine the tolerability of the dose range expected to be needed for later clinical studies and
to determine the nature of adverse reactions that can be expected.
Typically include both single and multiple dose administration
What phase are Initial Safety and Tolerability studies? - CORRECT ANSWERS Phase 1
What is pharmacokinetics? - CORRECT ANSWERS Body's effect on the drug
The absorption, distribution, metabolism and excretion of the drug in the human body
What phase are Pharmacokinetics studies? - CORRECT ANSWERS Phase 1
What phase are Pharmacodynamics
studies? - CORRECT ANSWERS Phase 1
What phase are Early Measurement of Drug Activity studies? - CORRECT ANSWERS Phase 1
What are characteristics of a Therapeutic Exploratory study? - CORRECT ANSWERS Primary
objective is to explore therapeutic efficacy in patients
Determine dose
Assessment of drug safety
Determine regimen
Evaluation of different target populations
Effectiveness of drug
Drug to drug interactions
What phase are Therapeutic Exploratory studies? - CORRECT ANSWERS Phase 2
And Correct Answers
What are examples of a Human Pharmacology study? - CORRECT ANSWERS Single and multiple
dose PK and/or PD studies
Dose-tolerance studies
Drug interaction studies
Early Measurement of Drug Activity
Dose response exploration studies are examples of what kind of trial? - CORRECT
ANSWERS Therapeutic Exploratory
The following studies describe what kind of trial?
- Comparative effectiveness studies
- Pharmacoeconomic studies - CORRECT ANSWERS Therapeutic Use
What are characteristics of a human pharmacological study? - CORRECT ANSWERS Usually have
non-therapeutic objectives
Initial administration to humans
Estimate initial safety and tolerance
Toxicity in Humans
Early Measurement of drug activity
Pharmacokinetics: Body's effect on the drug
-Pharmacodynamics: Drug's effect on the body
Pharmacokinetics: Body's effect on the drug
-Pharmacodynamics: Drug's effect on the body
What phase are Human Pharmacology studies? - CORRECT ANSWERS Phase 1
, What are characteristics of a Initial Safety and Tolerability study? - CORRECT ANSWERS Usually
intended to determine the tolerability of the dose range expected to be needed for later clinical studies and
to determine the nature of adverse reactions that can be expected.
Typically include both single and multiple dose administration
What phase are Initial Safety and Tolerability studies? - CORRECT ANSWERS Phase 1
What is pharmacokinetics? - CORRECT ANSWERS Body's effect on the drug
The absorption, distribution, metabolism and excretion of the drug in the human body
What phase are Pharmacokinetics studies? - CORRECT ANSWERS Phase 1
What phase are Pharmacodynamics
studies? - CORRECT ANSWERS Phase 1
What phase are Early Measurement of Drug Activity studies? - CORRECT ANSWERS Phase 1
What are characteristics of a Therapeutic Exploratory study? - CORRECT ANSWERS Primary
objective is to explore therapeutic efficacy in patients
Determine dose
Assessment of drug safety
Determine regimen
Evaluation of different target populations
Effectiveness of drug
Drug to drug interactions
What phase are Therapeutic Exploratory studies? - CORRECT ANSWERS Phase 2
