ICH E8 UPDATED ACTUAL Questions And
Correct Answers
Which trial phase's objectives include dose tolerance assessments? - CORRECT ANSWERS Phase
I - human pharmacology
Which trial phase's objectives include dose-response explorations? - CORRECT ANSWERS Phase
II - Therapeutic Exploratory
Which trial phase's objectives include confirming/establishing the dose-response relationships? -
CORRECT ANSWERS Phase III - Therapeutic Confirmatory
Which trial phase's objectives include mortality/morbidity outcomes and comparative effectiveness
studies? - CORRECT ANSWERS Phase IV - Therapeutic Use
What are some important considerations for determining the nature of non-clinical studies and their
timing with respect to clinical trials? - CORRECT ANSWERS 1) Duration and total exposure
proposed in individual patients
2) Drug Characteristics
3) Disease/condition targeted for treatment
4) Use in special populations
5) Route of administration
What should early non-clinical studies inform for phase I trials? - CORRECT ANSWERS 1)initial
human dose and safe duration of exposure
2) physiological and toxicological effects of a new drug
What are some elements of the non-clinical pharmacokinetic and pharmacology profile that inform the
basis and direction of clinical exploration? - CORRECT ANSWERS 1) Pharmacological basis of
principal effects (mechanism of action)
2) Dose-response or concentration-response relationships and duration of action
, 3) Study of potential clinical routes of administration
4) Systemic general pharmacology, including pharmacological effects on major organ systems and
physiological responses
5) Studies of absorption, distribution, metabolism & excretion
Which phase starts with the initial administration of an IP into humans? - CORRECT
ANSWERS Phase I
What type of patients are used in Phase I trials? - CORRECT ANSWERS Healthy volunteers or
certain types of patients such as mild hypertension
Sometimes seriously ill patient with no other options or when drug is toxic to healthy volunteers
(cytotoxic chemo agents)
What are typical aspects of Phase I trials? - CORRECT ANSWERS 1) Estimation of initial safety
and tolerability
2) Pharmacokinetics
3) Assessment of Pharmacodynamics
4) Early measurement of drug activity`
What is the most typical kind of Phase I study? - CORRECT ANSWERS Human pharmacology
What is the most typical kind of Phase II study? - CORRECT ANSWERS Therapeutic Exploratory
What is the primary objective of Phase II studies? - CORRECT ANSWERS Explore therapeutic
efficacy
What type of patients are typically used in Phase II studies? - CORRECT ANSWERS Group of
patients who are selected by relatively narrow criteria, leading to a relatively homogenous, closely
monitored population
Correct Answers
Which trial phase's objectives include dose tolerance assessments? - CORRECT ANSWERS Phase
I - human pharmacology
Which trial phase's objectives include dose-response explorations? - CORRECT ANSWERS Phase
II - Therapeutic Exploratory
Which trial phase's objectives include confirming/establishing the dose-response relationships? -
CORRECT ANSWERS Phase III - Therapeutic Confirmatory
Which trial phase's objectives include mortality/morbidity outcomes and comparative effectiveness
studies? - CORRECT ANSWERS Phase IV - Therapeutic Use
What are some important considerations for determining the nature of non-clinical studies and their
timing with respect to clinical trials? - CORRECT ANSWERS 1) Duration and total exposure
proposed in individual patients
2) Drug Characteristics
3) Disease/condition targeted for treatment
4) Use in special populations
5) Route of administration
What should early non-clinical studies inform for phase I trials? - CORRECT ANSWERS 1)initial
human dose and safe duration of exposure
2) physiological and toxicological effects of a new drug
What are some elements of the non-clinical pharmacokinetic and pharmacology profile that inform the
basis and direction of clinical exploration? - CORRECT ANSWERS 1) Pharmacological basis of
principal effects (mechanism of action)
2) Dose-response or concentration-response relationships and duration of action
, 3) Study of potential clinical routes of administration
4) Systemic general pharmacology, including pharmacological effects on major organ systems and
physiological responses
5) Studies of absorption, distribution, metabolism & excretion
Which phase starts with the initial administration of an IP into humans? - CORRECT
ANSWERS Phase I
What type of patients are used in Phase I trials? - CORRECT ANSWERS Healthy volunteers or
certain types of patients such as mild hypertension
Sometimes seriously ill patient with no other options or when drug is toxic to healthy volunteers
(cytotoxic chemo agents)
What are typical aspects of Phase I trials? - CORRECT ANSWERS 1) Estimation of initial safety
and tolerability
2) Pharmacokinetics
3) Assessment of Pharmacodynamics
4) Early measurement of drug activity`
What is the most typical kind of Phase I study? - CORRECT ANSWERS Human pharmacology
What is the most typical kind of Phase II study? - CORRECT ANSWERS Therapeutic Exploratory
What is the primary objective of Phase II studies? - CORRECT ANSWERS Explore therapeutic
efficacy
What type of patients are typically used in Phase II studies? - CORRECT ANSWERS Group of
patients who are selected by relatively narrow criteria, leading to a relatively homogenous, closely
monitored population
