CCRC EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL EXAM COMPLETE 600 QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+

1 | P a g e CCRC EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL EXAM COMPLETE 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 2 | P a g e 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 3 | P a g e a) Phase I studies b) Phase II studies c) a only d) 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 4 | P a g e 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 Powered by https://learnexams.com/search/study?query=

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