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CCRC EXAM, PRACTICE EXAM AND STUDY GUIDE
NEWEST 2024 ACTUAL EXAM COMP LETE 600
QUESTIONS AND CORRECT DETAILED ANSWERS
(VERIFIED ANSWERS ) |ALREADY GRADED A+
ICH defined Human pharmacology trial are
a) Phase I
b) Phase II
c) Phase Ill
d) Phase IV - ANSWER- a) Phase I
ICH defined Therapeutic Exploratory studies are likely to be
a) Phase I
b) Phase II
c) Phase Ill
d) Phase IV - ANSWER- b) Phase II
ICH defined Therapeutic Confirmatory studies re likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV - ANSWER- c) Phase III 1 / 4
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ICH defined Therapeutic Use studies are likely to be
a) Phase I
b) Phase II
c) Phase Ill
d) Phase IV - ANSWER- d) Phase IV
Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be
a) Human Pharmacology
b) Therapeutic Exploratory
c) Therapeutic Confirmatory
d) Therapeutic use - ANSWER- a) Human Pharmacology
Characterization of drug's absorption, metabolism and excretion
a) Are confined to Phase I studies
b) Cab be conducted in Phase II studies if Phase I studies are
inconclusive
c) Are never studied in Phase Ill studies
d) Continue throughout the development plan - ANSWER- d) Continue
throughout the development plan
Studies which provide the most information for confirmatory study design are part of 2 / 4
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a) Phase I studies
b) Phase II studies
- a only
- b only - ANSWER- d) b only
b) Phase II studies
Trials of short duration in narrow patient populations using pharmacological endpoints or clinical measures are likely to be
a) Phase I
b) Phase II
c) Phase Ill
d) Phase IV - ANSWER- b) Phase II
Studies which provide the most information for risk benefit relationship of a drug are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV - ANSWER- c) Phase III
Studies on which marketing approval hinges are likely to be
a) Phase I
b) Phase II
c) Phase III 3 / 4
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d) Phase IV - ANSWER- d) Phase IV
Epidemiologic and pharmacoeconomic studies are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV - ANSWER- d) Phase IV
Considerations for determining the nature and timing of non-clinical studies include
a) Duration and total exposure prosed in individual patients
b) Long half life
c) Route of administration
d) All of the above - ANSWER- d) All of the above
a) Duration and total exposure prosed in individual patients
b) Long half life
c) Route of administration
For first in human studies the administered dose should be determined by
a) Pharmacokinetics
b) Drug pharmacology
c) Toxicological evaluations
d) All of the above - ANSWER- d) All of the above
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