RAC Exam Practice 2024/2025 Questions and Answers 100% Correct
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Module
RAC
Institution
RAC
RAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% Correct
Which of the following was NOT a requirement of t...
Which of the following does not distinguish the development of drugs for
animal use from those for human use: a) The ability to use known data from
the development of a drug for use in humans or other animal species as
applicable. b) Generally safety and efficacy studies require only 10s of
animals per group compared to the 100s of patients per group required for
human drugs. c) Does not have user fees for NADAs. d) Species class and
breed of animals as well as geographical differences are more relevant.(3:1)
- ANSWER-C: Does not have user fees for NADAs.
A generic drug is deemed bioequivalent to the RLD if in clinical
bioequivalence studies the 90% confidence intervals for the ratio of
population geometric means between the two treatments based on log-
transformed data is contained within the equivalence limits of ____% - ____%
for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - ANSWER-
D: 80% and 125%
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